WorldWideScience

Sample records for safety review procedures

  1. Dexmedetomidine versus Midazolam in Procedural Sedation. A Systematic Review of Efficacy and Safety

    NARCIS (Netherlands)

    Barends, Clemens R. M.; Absalom, Anthony; van Minnen, Baucke; Vissink, Arjan; Visser, Anita

    2017-01-01

    Objectives To systematically review the literature comparing the efficacy and safety of dexmedetomidine and midazolam when used for procedural sedation. Materials and Methods We searched MEDLINE, EMBASE and COCHRANE for clinical trials comparing dexmedetomidine and midazolam for procedural sedation

  2. Development of a draft of human factors safety review procedures for the Korean next generation reactor

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Moon, B. S.; Park, J. C.; Lee, Y. H.; Oh, I. S.; Lee, H. C. [Korea Atomic Energy Research Institute, Taejeon (Korea)

    2000-02-01

    In this study, a draft of human factors engineering (HFE) safety review procedures (SRP) was developed for the safety review of KNGR based on HFE Safety and Regulatory Requirements and Guidelines (SRRG). This draft includes acceptance criteria, review procedure, and evaluation findings for the areas of review including HFE Program Management, Human Factors Analyses, Human Factors Design, and HFE Verification and Validation, based on Section 15.1 'Human Factors Engineering Design Process' and 15.2 'Control Room Human Factors Engineering' of KNGR Specific Safety Requirements and Chapter 15 'Human Factors Engineering' of KNGR Safety Regulatory Guides. For the effective review, human factors concerns or issues related to advanced HSI design that have been reported so far should be extensively examined. In this study, a total of 384 human factors issues related to the advanced HSI design were collected through our review of a total of 145 documents. A summary of each issue was described and the issues were identified by specific features of HSI design. These results were implemented into a database system. 8 refs., 2 figs. (Author)

  3. Effectiveness and safety of oral sedation in adult patients undergoing dental procedures: protocol for a systematic review

    OpenAIRE

    Araújo, Jimmy de Oliveira; Motta, Rogério Heládio Lopes; Bergamaschi, Cristiane de Cássia; Guimarães, Caio Chaves; Ramacciato, Juliana Cama; de Andrade, Natalia Karol; Fiqueiró, Mabel Fernandes; Lopes, Luciane Cruz

    2018-01-01

    Introduction The management of anxious patients undergoing dental procedures is still a challenge in clinical practice. Despite a wide variety of drugs for oral sedation in adult patients, there are relatively few systematic reviews that compare the effectiveness and safety of different drugs administered via this route. Thus, this study will evaluate the effectiveness and safety of oral sedation with benzodiazepines and other agents to patients undergoing dental surgical procedures. Method/d...

  4. A Review of Research on Procedures for Teaching Safety Skills to Persons with Developmental Disabilities

    Science.gov (United States)

    Dixon, Dennis R.; Bergstrom, Ryan; Smith, Marlena N.; Tarbox, Jonathan

    2010-01-01

    Safety skills are an important but often neglected area of training for persons with developmental disabilities (DD). The present study reviewed the literature on teaching safety skills to persons with DD. Safety skills involve a variety of behaviors such as knowing how to cross the street or what to do in case of a house fire. A number of studies…

  5. Regional anesthesia for pediatric knee surgery: a review of the indications, procedures, outcomes, safety, and challenges

    Directory of Open Access Journals (Sweden)

    Muhly WT

    2015-11-01

    Full Text Available Wallis T Muhly, Harshad G Gurnaney, Arjunan GaneshDepartment of Anesthesiology and Critical Care Medicine, The Children’s Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Pennsylvania, PA, USAAbstract: The indications for surgery on the knee in children and adolescents share some similarity to adult practice in that there are an increasing number of sports-related injuries requiring surgical repair. In addition, there are some unique age-related conditions or congenital abnormalities that may present as indications for orthopedic intervention at the level of the knee. The efficacy and safety of peripheral nerve blocks (PNBs for postoperative analgesia following orthopedic surgery has been well established in adults. Recent studies have also demonstrated earlier functional recovery after surgery in patients who received PNBs. In children, PNB is gaining popularity, and increasing data are emerging to demonstrate the feasibility, efficacy, and safety in this population. In this paper, we will review some of the most common indications for surgery involving the knee in children and the anatomy of knee, associated dermatomal and osteotomal innervation, and the PNBs most commonly used to produce analgesia at the level of the knee. We will review the evidence in support of regional anesthesia in children in terms of both the quality conferred to the immediate postoperative care and the role of continuous PNBs in maintaining effective analgesia following discharge. Also we will discuss some of the subtle challenges in utilizing regional anesthesia in the pediatric patient including the use of general anesthesia when performing regional anesthesia and the issue of monitoring for compartment syndrome. Finally, we will offer some thoughts about areas of practice that are in need of further investigation.Keywords: pediatric surgery, regional anesthesia, analgesia, knee surgery

  6. Assessing the safety and efficacy of drugs used in preparing the nose for diagnostic and therapeutic procedures: a systematic review.

    Science.gov (United States)

    Saif, A M; Farboud, A; Delfosse, E; Pope, L; Adke, M

    2016-10-01

    Local anaesthetics and vasoconstrictors are essential for pain control and to aid intra-operative haemostasis in nasal procedures. They also improve access, and reduce discomfort when performing nasal endoscopy. There are no clear guidelines on preparing the nose despite evermore diagnostic and therapeutic procedures utilising the nose as a point of access. This review aims to identify nasal preparations used in diagnostic and therapeutic nasal procedures and to examine their safety and efficacy. Systematic review. A search was carried out using PubMed, MEDLINE, Ovid EMBASE, the Cochrane library and references from the included articles. The inclusion criteria included: full-text English language articles with regard to nasal preparation for surgery. Case reports, systematic reviews, meta-analysis, double-blind placebo controlled randomised trials (RCTs) and case series were included. A total of 53 articles were retrieved: 13 articles on nasal preparation for operative procedures, six on functional endoscopic sinus surgery and 22 on nasendoscopy as well as six case reports. Cocaine was the most widely used topical preparation for operative procedures but was associated with more side-effects; thus, topical tetracaine and levobupivacaine infiltration are alternatives with equivalent efficacy but reduced adverse effects. All articles reviewed for functional endoscopic sinus surgery used a mixture containing lidocaine, adrenaline or both. Flexible nasendoscopy causes minimal patient discomfort and preparation is only recommended in selected patients, in contrast to rigid nasendoscopy which requires preparation. For operative procedures, such as septorhinoplasty, a single agent tetracaine or levobupivicaine provides an improved surgical field. In functional endoscopic sinus surgery, lidocaine-adrenaline preparations have resulted in significantly better surgical and patient outcomes. There is little evidence to support the routine use of pre-procedural nasal

  7. Radiation safety in nuclear medicine procedures

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Sang Geon; Kim, Ja Hae; Song, Ho Chun [Dept. of Nuclear Medicine, Medical Radiation Safety Research Center, Chonnam National University Hospital, Gwangju (Korea, Republic of)

    2017-03-15

    Since the nuclear disaster at the Fukushima Daiichi Nuclear Power Plant in 2011, radiation safety has become an important issue in nuclear medicine. Many structured guidelines or recommendations of various academic societies or international campaigns demonstrate important issues of radiation safety in nuclear medicine procedures. There are ongoing efforts to fulfill the basic principles of radiation protection in daily nuclear medicine practice. This article reviews important principles of radiation protection in nuclear medicine procedures. Useful references, important issues, future perspectives of the optimization of nuclear medicine procedures, and diagnostic reference level are also discussed.

  8. Radiation Safety in Nuclear Medicine Procedures.

    Science.gov (United States)

    Cho, Sang-Geon; Kim, Jahae; Song, Ho-Chun

    2017-03-01

    Since the nuclear disaster at the Fukushima Daiichi Nuclear Power Plant in 2011, radiation safety has become an important issue in nuclear medicine. Many structured guidelines or recommendations of various academic societies or international campaigns demonstrate important issues of radiation safety in nuclear medicine procedures. There are ongoing efforts to fulfill the basic principles of radiation protection in daily nuclear medicine practice. This article reviews important principles of radiation protection in nuclear medicine procedures. Useful references, important issues, future perspectives of the optimization of nuclear medicine procedures, and diagnostic reference level are also discussed.

  9. Patient safety improvement programmes for primary care. Review of a Delphi procedure and pilot studies by the LINNEAUS collaboration on patient safety in primary care

    Science.gov (United States)

    Verstappen, Wim; Gaal, Sander; Esmail, Aneez; Wensing, Michel

    2015-01-01

    ABSTRACT Background: To improve patient safety it is necessary to identify the causes of patient safety incidents, devise solutions and measure the (cost-) effectiveness of improvement efforts. Objective: This paper provides a broad overview with practical guidance on how to improve patient safety. Methods: We used modified online Delphi procedures to reach consensus on methods to improve patient safety and to identify important features of patient safety management in primary care. Two pilot studies were carried out to assess the value of prospective risk analysis (PRA), as a means of identifying the causes of a patient safety incident. Results: A range of different methods can be used to improve patient safety but they have to be contextually specific. Practice organization, culture, diagnostic errors and medication safety were found to be important domains for further improvement. Improvement strategies for patient safety could benefit from insights gained from research on implementation of evidence-based practice. Patient involvement and prospective risk analysis are two promising and innovative strategies for improving patient safety in primary care. Conclusion: A range of methods is available to improve patient safety, but there is no ‘magic bullet.’ Besides better use of the available methods, it is important to use new and potentially more effective strategies, such as prospective risk analysis. PMID:26339837

  10. Involving patients in patient safety programmes: A scoping review and consensus procedure by the LINNEAUS collaboration on patient safety in primary care

    NARCIS (Netherlands)

    Trier, H.; Valderas, J.M.; Wensing, M.; Martin, H.M.; Egebart, J.

    2015-01-01

    BACKGROUND: Patient involvement has only recently received attention as a potentially useful approach to patient safety in primary care. OBJECTIVE: To summarize work conducted on a scoping review of interventions focussing on patient involvement for patient safety; to develop consensus-based

  11. Arthroscopic latarjet procedure: safety evaluation in cadavers

    National Research Council Canada - National Science Library

    Gracitelli, Mauro Emilio Conforto; Ferreira, Arnaldo Amado; Benegas, Eduardo; Malavolta, Eduardo Angeli; Sunada, Edwin Eiji; Assunção, Jorge Henrique

    2013-01-01

    To evaluate the safety of arthroscopic Latarjet procedure in cadavers. : Twelve cadaveric shoulders underwent arthroscopic Latarjet procedure in our laboratory for arthroscopy, by four different surgeons...

  12. Involving patients in patient safety programmes: A scoping review and consensus procedure by the LINNEAUS collaboration on patient safety in primary care.

    Science.gov (United States)

    Trier, Hans; Valderas, Jose M; Wensing, Michel; Martin, Helle Max; Egebart, Jonas

    2015-09-01

    Patient involvement has only recently received attention as a potentially useful approach to patient safety in primary care. To summarize work conducted on a scoping review of interventions focussing on patient involvement for patient safety; to develop consensus-based recommendations in this area. Scoping review of the literature 2006-2011 about methods and effects of involving patients in patient safety in primary care identified evidence for previous experiences of patient involvement in patient safety. This information was fed back to an expert panel for the development of recommendations for healthcare professionals and policy makers. The scoping review identified only weak evidence in support of the effectiveness of patient involvement. Identified barriers included a number of patient factors but also the healthcare workers' attitudes, abilities and lack of training. The expert panel recommended the integration of patient safety in the educational curricula for healthcare professionals, and expected a commitment from professionals to act as first movers by inviting and encouraging the patients to take an active role. The panel proposed a checklist to be used by primary care clinicians at the point of care for promoting patient involvement. There is only weak evidence on the effectiveness of patient involvement in patient safety. The recommendations of the panel can inform future policy and practice on patient involvement in safety in primary care.

  13. The effect of facility characteristics on patient safety, patient experience, and service availability for procedures in non-hospital-affiliated outpatient settings: A systematic review.

    Science.gov (United States)

    Berglas, Nancy F; Battistelli, Molly F; Nicholson, Wanda K; Sobota, Mindy; Urman, Richard D; Roberts, Sarah C M

    2018-01-01

    Over recent decades, numerous medical procedures have migrated out of hospitals and into freestanding ambulatory surgery centers (ASCs) and physician offices, with possible implications for patient outcomes. In response, states have passed regulations for office-based surgeries, private organizations have established standards for facility accreditation, and professional associations have developed clinical guidelines. While abortions have been performed in office setting for decades, states have also enacted laws requiring that facilities that perform abortions meet specific requirements. The extent to which facility requirements have an impact on patient outcomes-for any procedure-is unclear. We conducted a systematic review to examine the effect of outpatient facility type (ASC vs. office) and specific facility characteristics (e.g., facility accreditation, emergency response protocols, clinician qualifications, physical plant characteristics, other policies) on patient safety, patient experience and service availability in non-hospital-affiliated outpatient settings. To identify relevant research, we searched databases of the published academic literature (PubMed, EMBASE, Web of Science) and websites of governmental and non-governmental organizations. Two investigators reviewed 3049 abstracts and full-text articles against inclusion/exclusion criteria and assessed the quality of 22 identified articles. Most studies were hampered by methodological challenges, with 12 of 22 not meeting minimum quality criteria. Of 10 studies included in the review, most (6) examined the effect of facility type on patient safety. Existing research appears to indicate no difference in patient safety for outpatient procedures performed in ASCs vs. physician offices. Research about specific facility characteristics is insufficient to draw conclusions. More and higher quality research is needed to determine if there is a public health problem to be addressed through facility

  14. Lift truck safety review

    Energy Technology Data Exchange (ETDEWEB)

    Cadwallader, L.C.

    1997-03-01

    This report presents safety information about powered industrial trucks. The basic lift truck, the counterbalanced sit down rider truck, is the primary focus of the report. Lift truck engineering is briefly described, then a hazard analysis is performed on the lift truck. Case histories and accident statistics are also given. Rules and regulations about lift trucks, such as the US Occupational Safety an Health Administration laws and the Underwriter`s Laboratories standards, are discussed. Safety issues with lift trucks are reviewed, and lift truck safety and reliability are discussed. Some quantitative reliability values are given.

  15. Patient safety improvement programmes for primary care. Review of a Delphi procedure and pilot studies by the LINNEAUS collaboration on patient safety in primary care

    NARCIS (Netherlands)

    Verstappen, W.H.; Gaal, S.; Esmail, A.; Wensing, M.

    2015-01-01

    BACKGROUND: To improve patient safety it is necessary to identify the causes of patient safety incidents, devise solutions and measure the (cost-) effectiveness of improvement efforts. OBJECTIVE: This paper provides a broad overview with practical guidance on how to improve patient safety. METHODS:

  16. Road safety audit tools, procedures, and experiences : a literature review and recommendations : research in the framework of the European research project Safety Standards for Road Design and Redesign SAFESTAR, Workpackage 8.

    NARCIS (Netherlands)

    Kooi, R.M. van der

    1999-01-01

    This report describes tools and procedures established in different countries which apply Road Safety Audits (RSA). These RSAs are utilized to identify potential safety problems and they concentrate on safety measures to overcome these problems. This technique is used to detect possible safety

  17. Aviation Safety Reporting System: Process and Procedures

    Science.gov (United States)

    Connell, Linda J.

    1997-01-01

    The Aviation Safety Reporting System (ASRS) was established in 1976 under an agreement between the Federal Aviation Administration (FAA) and the National Aeronautics and Space Administration (NASA). This cooperative safety program invites pilots, air traffic controllers, flight attendants, maintenance personnel, and others to voluntarily report to NASA any aviation incident or safety hazard. The FAA provides most of the program funding. NASA administers the program, sets its policies in consultation with the FAA and aviation community, and receives the reports submitted to the program. The FAA offers those who use the ASRS program two important reporting guarantees: confidentiality and limited immunity. Reports sent to ASRS are held in strict confidence. More than 350,000 reports have been submitted since the program's beginning without a single reporter's identity being revealed. ASRS removes all personal names and other potentially identifying information before entering reports into its database. This system is a very successful, proof-of-concept for gathering safety data in order to provide timely information about safety issues. The ASRS information is crucial to aviation safety efforts both nationally and internationally. It can be utilized as the first step in safety by providing the direction and content to informed policies, procedures, and research, especially human factors. The ASRS process and procedures will be presented as one model of safety reporting feedback systems.

  18. Safety & Usage Procedure for Lithium Polymer Batteries

    OpenAIRE

    Naval Postgraduate School (U.S.)

    2014-01-01

    Version 1.4; July 2014 This document establishes procedures for safety and use of Lithium Polymer Battery technology in the Naval Postgraduate School (NPS), including Unmanned Aircraft Systems (UAS). All faculty, staff and students wishing to become Authorized Users of Lithium Polymer batteries shall be required to read and acknowledge this document and act in accordance with all procedures contained herein to be granted access to Lithium Polymer batteries.

  19. Efficacy and safety outcomes of recanalisation procedures in patients with acute symptomatic pulmonary embolism: systematic review and network meta-analysis.

    Science.gov (United States)

    Jimenez, David; Martin-Saborido, Carlos; Muriel, Alfonso; Zamora, Javier; Morillo, Raquel; Barrios, Deisy; Klok, Frederikus A; Huisman, Menno V; Tapson, Victor; Yusen, Roger D

    2017-11-13

    We aimed to review the efficacy and safety of recanalisation procedures for the treatment of PE. We searched PubMed, the Cochrane Library, EMBASE, EBSCO, Web of Science and CINAHL databases from inception through 31 July 2015 and included randomised clinical trials that compared the effect of a recanalisation procedure versus each other or anticoagulant therapy in patients diagnosed with PE. We used network meta-analysis and multivariate random-effects meta-regression to estimate pooled differences between each intervention and meta-regression to assess the association between trial characteristics and the reported effects of recanalisation procedures versus anticoagulation. For all-cause mortality, there were no significant differences in event rates between any of the recanalisation procedures and anticoagulant treatment (full-dose thrombolysis: OR 0.60; 95% CI0.36 to 1.01; low-dose thrombolysis: 0.47; 95% CI 0.14 to 1.59; and catheter-associated thrombolysis: 0.31; 95% CI 0.01 to 7.96). Full-dose thrombolysis increased the risk of major bleeding (2.00; 95% CI 1.06 to 3.78) compared with anticoagulation. Catheter-directed thrombolysis was associated with the lowest probability of dying (surface under the cumulative ranking curve (SUCRA), 0.67), followed by low-dose thrombolysis (SUCRA, 0.66) and full-dose thrombolysis (SUCRA, 0.55). Similarly, low-dose thrombolysis was associated with the lowest probability of major bleeding (SUCRA, 0.61), followed by catheter-directed thrombolysis (SUCRA, 0.54) and full-dose thrombolysis (SUCRA, 0.17). The results were similar in sensitivity analyses based on restricting only to studies in haemodynamically stable patients with PE. In the treatment of PE, recanalisation procedures do not seem to offer a clear advantage compared with standard anticoagulation. Low-dose thrombolysis was associated with the lowest probability of dying and bleeding. PROSPERO CRD42015024670. © Article author(s) (or their employer(s) unless

  20. Translation and review on the IAEA safety standards and guides

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Sang Hoon; Lee, Yeong Hwan; Moon, Seok Hyeong; Sohn, Moon Kyu [Korea Association for Nuclear Technology, Taejon (Korea, Republic of)

    2000-12-15

    Translation and review of five IAEA safety guides as follows : staffing of Nuclear Power Plants and the recruitment, training and authorization of operating personnel (safety series No. 50-SG-01), in-service inspection for Nuclear Power Plants (safety series No. 50-SG-02), operating limits and conditions for Nuclear Power Plants (safety series No. 50-SG-03), commissioning procedures for Nuclear Power Plants (safety series No. 50-SG-04), maintenance of Nuclear Power Plants (safety series No. 50-SG-07)

  1. Safety of Cargo Aircraft Handling Procedure

    Directory of Open Access Journals (Sweden)

    Daniel Hlavatý

    2017-07-01

    Full Text Available The aim of this paper is to get acquainted with the ways how to improve the safety management system during cargo aircraft handling. The first chapter is dedicated to general information about air cargo transportation. This includes the history or types of cargo aircraft handling, but also the means of handling. The second part is focused on detailed description of cargo aircraft handling, including a description of activities that are performed before and after handling. The following part of this paper covers a theoretical interpretation of safety, safety indicators and legislative provisions related to the safety of cargo aircraft handling. The fourth part of this paper analyzes the fault trees of events which might occur during handling. The factors found by this analysis are compared with safety reports of FedEx. Based on the comparison, there is a proposal on how to improve the safety management in this transportation company.

  2. 78 FR 58897 - Pipeline Safety: Administrative Procedures; Updates and Technical Corrections

    Science.gov (United States)

    2013-09-25

    ... basic fairness in both the administrative process and upon judicial review, the respondent should ] be...: Administrative Procedures; Updates and Technical Corrections AGENCY: Pipeline and Hazardous Materials Safety... update the administrative civil penalty maximums for violation of the safety standards to reflect current...

  3. Trapping safety into rules how desirable or avoidable is proceduralization?

    CERN Document Server

    Bourrier, Mathilde

    2013-01-01

    Rules and procedures are key features for a modern organization to function. It is no surprise to see them to be paramount in safety management. As some sociologists argue, routine and rule following is not always socially resented. It can bring people comfort and reduce anxieties of newness and uncertainty. Facing constant unexpected events entails fatigue and exhaustion. There is also no doubt that proceduralization and documented activities have brought progress, avoided recurrent mistakes and allowed for 'best practices' to be adopted. However, it seems that the exclusive and intensive use of procedures today is in fact a threat to new progress in safety. There is an urgent need to consider this issue because there is doubt that the path chosen by many hazardous industries and activities is the most effective, safety wise, considering the safety level achieved today. As soon as safety is involved, there seems to be an irresistible push towards a wider scope of norms, procedures and processes, whatever the...

  4. A review of mammalian carcinogenicity study design and potential effects of alternate test procedures on the safety evaluation of food ingredients.

    Science.gov (United States)

    Hayes, A W; Dayan, A D; Hall, W C; Kodell, R L; Williams, G M; Waddell, W D; Slesinski, R S; Kruger, C L

    2011-06-01

    Extensive experience in conducting long term cancer bioassays has been gained over the past 50 years of animal testing on drugs, pesticides, industrial chemicals, food additives and consumer products. Testing protocols for the conduct of carcinogenicity studies in rodents have been developed in Guidelines promulgated by regulatory agencies, including the US EPA (Environmental Protection Agency), the US FDA (Food and Drug Administration), the OECD (Organization for Economic Co-operation and Development) for the EU member states and the MAFF (Ministries of Agriculture, Forestries and Fisheries) and MHW (Ministry of Health and Welfare) in Japan. The basis of critical elements of the study design that lead to an accepted identification of the carcinogenic hazard of substances in food and beverages is the focus of this review. The approaches used by entities well-known for carcinogenicity testing and/or guideline development are discussed. Particular focus is placed on comparison of testing programs used by the US National Toxicology Program (NTP) and advocated in OECD guidelines to the testing programs of the European Ramazzini Foundation (ERF), an organization with numerous published carcinogenicity studies. This focus allows for a good comparison of differences in approaches to carcinogenicity testing and allows for a critical consideration of elements important to appropriate carcinogenicity study designs and practices. OECD protocols serve as good standard models for carcinogenicity testing protocol design. Additionally, the detailed design of any protocol should include attention to the rationale for inclusion of particular elements, including the impact of those elements on study interpretations. Appropriate interpretation of study results is dependent on rigorous evaluation of the study design and conduct, including differences from standard practices. Important considerations are differences in the strain of animal used, diet and housing practices, rigorousness

  5. Bilateral effects of hospital patient-safety procedures on nurses' job satisfaction.

    Science.gov (United States)

    Inoue, T; Karima, R; Harada, K

    2017-09-01

    The aim of this study was to examine how hospital patient-safety procedures affect the job satisfaction of hospital nurses. Additionally, we investigated the association between perceived autonomy and hospital patient-safety procedures and job satisfaction. Recently, measures for patient safety have been recognized as an essential requirement in hospitals. Hospital patient-safety procedures may enhance the job satisfaction of nurses by improving the quality of their work. However, such procedures may also decrease their job satisfaction by imposing excessive stress on nurses because they cannot make mistakes. The participants included 537 nurses at 10 private hospitals in Japan (The surveys were collected from March to July 2012). Factors related to hospital patient-safety procedures were demonstrated using factor analysis, and the associations between these factors and nurses' self-perceived autonomy and job satisfaction were examined using structural equation modelling. Five factors regarding hospital patient-safety procedures were extracted. Additionally, structural equation modelling revealed statistically significant associations between these factors and the nurses' self-perceived autonomy and job satisfaction. The findings showed that nurses' perceived autonomy of the workplace enhanced their job satisfaction and that their perceptions of hospital patient-safety procedures promoted their job satisfaction. However, some styles of chief nurses' leadership regarding patient safety restrict nurses' independent and autonomous decision-making and actions, resulting in a lowering of job satisfaction. This study demonstrated that hospital patient-safety procedures have ambiguous effects on nurses' job satisfaction. In particular, chief nurses' leadership relating to patient safety can have a positive or negative effect on nurses' job satisfaction. The findings indicated that hospital managers should demonstrate positive attitudes to improve patient safety for

  6. Procedure-modular specification and verification of temporal safety properties

    NARCIS (Netherlands)

    Soleimanifard, Siavash; Gurov, Dilian; Huisman, Marieke

    This paper describes ProMoVer, a tool for fully automated procedure-modular verification of Java programs equipped with method-local and global assertions that specify safety properties of sequences of method invocations. Modularity at the procedure-level is a natural instantiation of the modular

  7. Health and Safety Procedures Manual for hazardous waste sites

    Energy Technology Data Exchange (ETDEWEB)

    Thate, J.E.

    1992-09-01

    The Oak Ridge National Laboratory Chemical Assessments Team (ORNL/CAT) has developed this Health and Safety Procedures Manual for the guidance, instruction, and protection of ORNL/CAT personnel expected to be involved in hazardous waste site assessments and remedial actions. This manual addresses general and site-specific concerns for protecting personnel, the general public, and the environment from any possible hazardous exposures. The components of this manual include: medical surveillance, guidance for determination and monitoring of hazards, personnel and training requirements, protective clothing and equipment requirements, procedures for controlling work functions, procedures for handling emergency response situations, decontamination procedures for personnel and equipment, associated legal requirements, and safe drilling practices.

  8. Forthcoming indefinite contract review procedure

    CERN Multimedia

    Human Resources Department

    2011-01-01

    The vacancy notices for posts opened with a view to the award of an indefinite contract will be published in early April 2011. In the meantime, the list of posts to be opened this spring is available at the following address: Indefinite contract posts - spring 2011 A second exercise will take place in autumn 2011 and, as of 2012, the indefinite contract award procedure will only be held once a year, in autumn. For more information please consult: https://hr-recruit.web.cern.ch/hr-recruit/staff/IndefiniteContracts.asp  

  9. Safety Practices for Demolition Procedures. Module SH-41. Safety and Health.

    Science.gov (United States)

    Center for Occupational Research and Development, Inc., Waco, TX.

    This student module on safety practices for demolition procedures is one of 50 modules concerned with job safety and health. This module presents a general outline of the safe work practices that should be followed at a demolition job site in order for workers to avoid injury. Following the introduction, 10 objectives (each keyed to a page in the…

  10. Procedure-Modular Verification of Control Flow Safety Properties

    NARCIS (Netherlands)

    Soleimanifard, Siavash; Gurov, Dilian; Huisman, Marieke

    2010-01-01

    This paper describes a novel technique for fully automated procedure-modular verification of Java programs equipped with method-local and global assertions that specify safety properties of sequences of method invocations. Modularity of verification is achieved by relativizing the correctness of

  11. Internet Safety and Security Surveys - A Review

    DEFF Research Database (Denmark)

    Sharp, Robin

    This report gives a review of investigations into Internet safety and security over the last 10 years. The review covers a number of surveys of Internet usage, of Internet security in general, and of Internet users' awareness of issues related to safety and security. The focus and approach...

  12. A literature review of safety culture.

    Energy Technology Data Exchange (ETDEWEB)

    Cole, Kerstan Suzanne; Stevens-Adams, Susan Marie; Wenner, Caren A.

    2013-03-01

    Workplace safety has been historically neglected by organizations in order to enhance profitability. Over the past 30 years, safety concerns and attention to safety have increased due to a series of disastrous events occurring across many different industries (e.g., Chernobyl, Upper Big-Branch Mine, Davis-Besse etc.). Many organizations have focused on promoting a healthy safety culture as a way to understand past incidents, and to prevent future disasters. There is an extensive academic literature devoted to safety culture, and the Department of Energy has also published a significant number of documents related to safety culture. The purpose of the current endeavor was to conduct a review of the safety culture literature in order to understand definitions, methodologies, models, and successful interventions for improving safety culture. After reviewing the literature, we observed four emerging themes. First, it was apparent that although safety culture is a valuable construct, it has some inherent weaknesses. For example, there is no common definition of safety culture and no standard way for assessing the construct. Second, it is apparent that researchers know how to measure particular components of safety culture, with specific focus on individual and organizational factors. Such existing methodologies can be leveraged for future assessments. Third, based on the published literature, the relationship between safety culture and performance is tenuous at best. There are few empirical studies that examine the relationship between safety culture and safety performance metrics. Further, most of these studies do not include a description of the implementation of interventions to improve safety culture, or do not measure the effect of these interventions on safety culture or performance. Fourth, safety culture is best viewed as a dynamic, multi-faceted overall system composed of individual, engineered and organizational models. By addressing all three components of

  13. Splash Safety During Dermatologic Procedures Among US Dermatology Residents.

    Science.gov (United States)

    Korta, Dorota Z; Chapman, Lance W; Lee, Patrick K; Linden, Kenneth G

    2017-07-01

    Dermatologists are at potential risk of acquiring infections from contamination of the mucous membranes by blood and body fluids. However, there are little data on splash safety during procedural dermatology. To determine dermatology resident perceptions about splash risk during dermatologic procedures and to quantify the rate of protective equipment use. An anonymous on-line survey was sent to 108 United States ACGME-approved dermatology residency programs assessing frequency of facial protection during dermatologic procedures, personal history of splash injury, and, if applicable, reasons for not always wearing facial protection. A total of 153 dermatology residents responded. Rates of facial protection varied by procedure, with the highest rates during surgery and the lowest during local anesthetic injection. Over 54% of respondents reported suffering facial splash while not wearing facial protection during a procedure. In contrast, 88.9% of respondents correctly answered that there is a small risk of acquiring infection from mucosal splash. Residency program recommendations for facial protection seem to vary by procedure. The authors' results demonstrate that although facial splash is a common injury, facial protection rates and protective recommendations vary significantly by procedure. These data support the recommendation for enhanced facial protection guidelines during procedural dermatology.

  14. Packaging Review Guide for Reviewing Safety Analysis Reports for Packagings

    Energy Technology Data Exchange (ETDEWEB)

    DiSabatino, A; Biswas, D; DeMicco, M; Fisher, L E; Hafner, R; Haslam, J; Mok, G; Patel, C; Russell, E

    2007-04-12

    This Packaging Review Guide (PRG) provides guidance for Department of Energy (DOE) review and approval of packagings to transport fissile and Type B quantities of radioactive material. It fulfills, in part, the requirements of DOE Order 460.1B for the Headquarters Certifying Official to establish standards and to provide guidance for the preparation of Safety Analysis Reports for Packagings (SARPs). This PRG is intended for use by the Headquarters Certifying Official and his or her review staff, DOE Secretarial offices, operations/field offices, and applicants for DOE packaging approval. This PRG is generally organized at the section level in a format similar to that recommended in Regulatory Guide 7.9 (RG 7.9). One notable exception is the addition of Section 9 (Quality Assurance), which is not included as a separate chapter in RG 7.9. Within each section, this PRG addresses the technical and regulatory bases for the review, the manner in which the review is accomplished, and findings that are generally applicable for a package that meets the approval standards. This Packaging Review Guide (PRG) provides guidance for DOE review and approval of packagings to transport fissile and Type B quantities of radioactive material. It fulfills, in part, the requirements of DOE O 460.1B for the Headquarters Certifying Official to establish standards and to provide guidance for the preparation of Safety Analysis Reports for Packagings (SARPs). This PRG is intended for use by the Headquarters Certifying Official and his review staff, DOE Secretarial offices, operations/field offices, and applicants for DOE packaging approval. The primary objectives of this PRG are to: (1) Summarize the regulatory requirements for package approval; (2) Describe the technical review procedures by which DOE determines that these requirements have been satisfied; (3) Establish and maintain the quality and uniformity of reviews; (4) Define the base from which to evaluate proposed changes in scope

  15. 29 CFR 2200.108 - Official Seal of the Occupational Safety and Health Review Commission.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Official Seal of the Occupational Safety and Health Review... HEALTH REVIEW COMMISSION RULES OF PROCEDURE Miscellaneous Provisions § 2200.108 Official Seal of the Occupational Safety and Health Review Commission. The seal of the Commission shall consist of: A gold eagle...

  16. 23 CFR 630.1106 - Policy and procedures for work zone safety management.

    Science.gov (United States)

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Policy and procedures for work zone safety management... Policy and procedures for work zone safety management. (a) Each agency's policy and processes, procedures... procedures to determine project-specific services; (5) Appropriate work zone safety and mobility training for...

  17. Occupational Safety Review of High Technology Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Lee Cadwallader

    2005-01-31

    This report contains reviews of operating experiences, selected accident events, and industrial safety performance indicators that document the performance of the major US DOE magnetic fusion experiments and particle accelerators. These data are useful to form a basis for the occupational safety level at matured research facilities with known sets of safety rules and regulations. Some of the issues discussed are radiation safety, electromagnetic energy exposure events, and some of the more widespread issues of working at height, equipment fires, confined space work, electrical work, and other industrial hazards. Nuclear power plant industrial safety data are also included for comparison.

  18. Risk and safety requirements for diagnostic and therapeutic procedures in allergology: World Allergy Organization Statement.

    Science.gov (United States)

    Kowalski, Marek L; Ansotegui, Ignacio; Aberer, Werner; Al-Ahmad, Mona; Akdis, Mubeccel; Ballmer-Weber, Barbara K; Beyer, Kirsten; Blanca, Miguel; Brown, Simon; Bunnag, Chaweewan; Hulett, Arnaldo Capriles; Castells, Mariana; Chng, Hiok Hee; De Blay, Frederic; Ebisawa, Motohiro; Fineman, Stanley; Golden, David B K; Haahtela, Tari; Kaliner, Michael; Katelaris, Connie; Lee, Bee Wah; Makowska, Joanna; Muller, Ulrich; Mullol, Joaquim; Oppenheimer, John; Park, Hae-Sim; Parkerson, James; Passalacqua, Giovanni; Pawankar, Ruby; Renz, Harald; Rueff, Franziska; Sanchez-Borges, Mario; Sastre, Joaquin; Scadding, Glenis; Sicherer, Scott; Tantilipikorn, Pongsakorn; Tracy, James; van Kempen, Vera; Bohle, Barbara; Canonica, G Walter; Caraballo, Luis; Gomez, Maximiliano; Ito, Komei; Jensen-Jarolim, Erika; Larche, Mark; Melioli, Giovanni; Poulsen, Lars K; Valenta, Rudolf; Zuberbier, Torsten

    2016-01-01

    One of the major concerns in the practice of allergy is related to the safety of procedures for the diagnosis and treatment of allergic disease. Management (diagnosis and treatment) of hypersensitivity disorders involves often intentional exposure to potentially allergenic substances (during skin testing), deliberate induction in the office of allergic symptoms to offending compounds (provocation tests) or intentional application of potentially dangerous substances (allergy vaccine) to sensitized patients. These situations may be associated with a significant risk of unwanted, excessive or even dangerous reactions, which in many instances cannot be completely avoided. However, adverse reactions can be minimized or even avoided if a physician is fully aware of potential risk and is prepared to appropriately handle the situation. Information on the risk of diagnostic and therapeutic procedures in allergic diseases has been accumulated in the medical literature for decades; however, except for allergen specific immunotherapy, it has never been presented in a systematic fashion. Up to now no single document addressed the risk of the most commonly used medical procedures in the allergy office nor attempted to present general requirements necessary to assure the safety of these procedures. Following review of available literature a group of allergy experts within the World Allergy Organization (WAO), representing various continents and areas of allergy expertise, presents this report on risk associated with diagnostic and therapeutic procedures in allergology and proposes a consensus on safety requirements for performing procedures in allergy offices. Optimal safety measures including appropriate location, type and required time of supervision, availability of safety equipment, access to specialized emergency services, etc. for various procedures have been recommended. This document should be useful for allergists with already established practices and experience as well

  19. Risk and safety requirements for diagnostic and therapeutic procedures in allergology: World Allergy Organization Statement

    Directory of Open Access Journals (Sweden)

    Marek L. Kowalski

    2016-10-01

    Full Text Available Abstract One of the major concerns in the practice of allergy is related to the safety of procedures for the diagnosis and treatment of allergic disease. Management (diagnosis and treatment of hypersensitivity disorders involves often intentional exposure to potentially allergenic substances (during skin testing, deliberate induction in the office of allergic symptoms to offending compounds (provocation tests or intentional application of potentially dangerous substances (allergy vaccine to sensitized patients. These situations may be associated with a significant risk of unwanted, excessive or even dangerous reactions, which in many instances cannot be completely avoided. However, adverse reactions can be minimized or even avoided if a physician is fully aware of potential risk and is prepared to appropriately handle the situation. Information on the risk of diagnostic and therapeutic procedures in allergic diseases has been accumulated in the medical literature for decades; however, except for allergen specific immunotherapy, it has never been presented in a systematic fashion. Up to now no single document addressed the risk of the most commonly used medical procedures in the allergy office nor attempted to present general requirements necessary to assure the safety of these procedures. Following review of available literature a group of allergy experts within the World Allergy Organization (WAO, representing various continents and areas of allergy expertise, presents this report on risk associated with diagnostic and therapeutic procedures in allergology and proposes a consensus on safety requirements for performing procedures in allergy offices. Optimal safety measures including appropriate location, type and required time of supervision, availability of safety equipment, access to specialized emergency services, etc. for various procedures have been recommended. This document should be useful for allergists with already established

  20. Year 2000 TWRS Maintenance procedure review report

    Energy Technology Data Exchange (ETDEWEB)

    ADAMS, M.R.

    1999-02-24

    A concern exists that some equipment in use might contain microprocessors that are dependent upon a time date function. The majority of the software programming for microprocessors has only utilized a 2 digit identifier for the year. With the approach of the year 2000, (Y2K), there is concern that the date function will not be correctly recognized and some functions will not operate properly. TWRS maintenance procedures have been reviewed to identify equipment components that may not be Y2K compliant. Engineering judgment was utilized to eliminate procedures and equipment that is obviously not impacted by Y2K.

  1. Evaluation procedure of software safety plan for digital I and C of KNGR

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jang Soo; Park, Jong Kyun; Lee, Ki Young; Kwon, Ki Choon; Kim, Jang Yeol; Cheon, Se Woo

    2000-05-01

    The development, use, and regulation of computer systems in nuclear reactor instrumentation and control (I and C) systems to enhance reliability and safety is a complex issue. This report is one of a series of reports from the Korean next generation reactor (KNGR) software safety verification and validation (SSVV) task, Korea Atomic Energy Research Institute, which investigates different aspects of computer software in reactor I and C systems, and describes the engineering procedures for developing such a software. The purpose of this guideline is to give the software safety evaluator the trail map between the code and standards layer and the design methodology and documents layer for the software important to safety in nuclear power plants. Recently, the safety planning for safety-critical software systems is being recognized as the most important phase in the software life cycle, and being developed new regulatory positions and standards by the regulatory and the standardization organizations. The requirements for software important to safety of nuclear reactor are described in such positions and standards, for example, the new standard review plan (SRP), IEC 880 supplements, IEEE standard 1228-1994, IEEE standard 7-4.3.2-1993, and IAEA safety series No. 50-SG-D3 and D8. We presented the guidance for evaluating the safety plan of the software in the KNGR protection systems. The guideline consists of the regulatory requirements for software safety in chapter 2, the evaluation checklist of software safety plan in chapter3, and the evaluation results of KNGR software safety plan in chapter 4.

  2. 49 CFR 214.335 - On-track safety procedures for roadway work groups.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false On-track safety procedures for roadway work groups... Protection § 214.335 On-track safety procedures for roadway work groups. (a) No employer subject to the...-track safety of the roadway work group that on-track safety is provided. (c) Roadway work groups engaged...

  3. Safety considerations for office-based obstetric and gynecologic procedures.

    Science.gov (United States)

    Urman, Richard D; Punwani, Nathan; Bombaugh, Maryanne; Shapiro, Fred E

    2013-01-01

    The migration of gynecologic procedures to office-based settings provides numerous advantages for patients and providers alike, including reduced patient expenses, improved scheduling convenience, favorable provider reimbursement, and enhanced continuity of care and patient satisfaction. With rising health care costs-a major concern in health care-procedures will continue to shift to practice environments that optimize care, quality, value, and efficiency. It is imperative that gynecologic offices ensure that performance and quality variations are minimized across different sites of care; physicians should strive to provide care to patients that optimizes safety and is at least equivalent to that delivered at traditional sites. The gynecologic community should nonetheless heed the Institute of Medicine's recommendations and embrace continuous quality improvement. By exercising leadership, office-based gynecologists can forge a culture of competency, teamwork, communication, and performance measurement.

  4. Review of the IEEE Standard for Computerized Operating Procedure Systems

    Energy Technology Data Exchange (ETDEWEB)

    O' Hara, J.; Higgins, J.

    2010-02-26

    Increasingly nuclear power plant procedures, such as emergency operating procedures, are being presented in computer form with functionality to support operator use and management of the procedures. The U.S. Nuclear Regulatory Commission (NRC) currently has guidance for the review of computer-based procedures (CBPs); however, there remain CBP functions and human performance issues for which up-to-date guidance is lacking. The Institute of Electrical and Electronics Engineers (IEEE) has initiated a standard development effort to address the human factors engineering (HFE) aspects of CBP systems. When completed, it may provide guidance to supplement the NRC staff's review criteria. The purpose of our study was to evaluate the suitability of the IEEE Standard for use in the NRC's HFE safety reviews of CBP systems and to ensure that the guidance meets the NRC's standard for scientific and engineering rigor used in its own guidance development efforts. We established the following criteria with which to evaluate the Standard: (1) it should meet an existing need of NRC reviewers, (2) it should be based in sound HFE principles, (3) it should be thoroughly peer-reviewed, and (4) it should address CBP-related human performance issues identified in the literature. This report describes the methodology we used to evaluate each criterion. Our evaluation concluded that the Standard generally does meet these criteria, however several areas were identified for which additional clarifications are needed. Thus consideration of the Standard's use by the NRC is supported. The standard evaluation methodology developed in this study can be generally applied to the review of other HFE standards being considered for possible use or endorsement by the NRC.

  5. REVIEW OF SAFETY AND TOLERANCE OF OMALIZUMAB

    Directory of Open Access Journals (Sweden)

    A.V. Emel'yanov

    2008-01-01

    Full Text Available The review of safety of monoclonal anti-ige-antibodies (xolair — a new medication for the treatment of severe allergic bronchial asthma is presented. Local and system adverse events, originating after injection of medicament in clinical studies and following administration in patients are discussed.Key words: children, bronchial asthma, monoclonal anti Ige antibodies.

  6. Literature review regarding patient safety culture.

    Science.gov (United States)

    Xuanyue, Mao; Yanli, Nie; Hao, Cui; Pengli, Jia; Mingming, Zhang

    2013-02-01

    Quite a number of articles on patient safety culture have been published in recent 10 years to assess the safety culture in hospitals using the Hospital Survey on Patient Safety Culture in many countries. However, until now there have been no relevant studies to investigate the quality of these, and their contribution to present-day thinking. The aim of this study was to explore the areas of theme, and the study design of published research on patient safety culture in literature published in English and Chinese language journals. We searched the major databases, including MEDLINE, EMbase, Chinese Biomedical Literature Database, Chinese Journals Full-text Database, and to analyze the publication years, research themes, authors' affiliations and methodologies of articles published from January 2001 to December 2011. Quality and statistical method were only appraised by classification of study designs. The annual number of published articles on patient safety culture was increasing in the last decade, and the number of articles published in 2010 and 2011 reached its peak with 86 articles accounting for 44.6% of the decade's publication; patient safety culture scale dominated the included literature, accounting for 67.8% of all studies. Cross-sectional studies and commentary reviews were the most popular study designs which took up approximately 95.9% of the included studies with 66.9% (129 articles) and 29.0% (56 articles), respectively. All the included studies on patient safety culture were conducted in the following four institutions: hospitals, geracomium, Veterans Health Administration hospitals, and medical schools. There is a growing change trend in the number of articles on patient safety culture research in recent 10 years, most of which are non-comparative studies. More methodologically rigorous designs are needed to improve research quality on patient safety culture. © 2013 Wiley Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of

  7. [Mood induction procedures: a critical review].

    Science.gov (United States)

    Gilet, A-L

    2008-06-01

    For a long period in the history of psychological research, emotion and cognition have been studied independently, as if one were irrelevant to the other. The renewed interest of researchers for the study of the relations between cognition and emotion has led to the development of a range of laboratory methods for inducing temporary mood states. This paper aims to review the main mood induction procedures allowing the induction of a negative mood as well as a positive mood, developed since the pioneer study of Schachter and Singer [Psychol Rev 69 (1962) 379-399] and to account for the usefulness and problems related to the use of such techniques. The first part of this paper deals with the detailed presentation of some of the most popular mood induction procedures according to their type: simple (use of only one mood induction technique) or combined (association of two or more techniques at once). The earliest of the modern techniques is the Velten Mood Induction Procedure [Behav Res Ther 6 (1968) 473-482], which involves reading aloud sixty self-referent statements progressing from relative neutral mood to negative mood or dysphoria. Some researchers have varied the procedure slightly by changing the number of the statements [Behav Res Ther 21 (1983) 233-239, Br J Clin Psychol 21 (1982) 111-117, J Pers Soc Psychol 35 (1977) 625-636]. Various other mood induction procedures have been developed including music induction [Cogn Emotion 11 (1997) 403-432, Br J Med Psychol 55 (1982) 127-138], film clip induction [J Pers Soc Psychol 20 (1971) 37-43, Cogn Emotion 7 (1993) 171-193, Rottenberg J, Ray RR, Gross JJ. Emotion elicitation using films. In: Coan JA, Allen JJB, editors. The handbook of emotion elicitation and assessment. New York: Oxford University Press, 2007], autobiographical recall [J Clin Psychol 36 (1980) 215-226, Jallais C. Effets des humeurs positives et négatives sur les structures de connaissances de type script. Thèse de doctorat non publi

  8. Safety signal detection: the relevance of literature review.

    Science.gov (United States)

    Pontes, Helena; Clément, Mallorie; Rollason, Victoria

    2014-07-01

    Adverse drug reactions (ADRs) represent an important risk for patients and have a significant economic impact on health systems. ADRs are the fifth most common cause of hospital death, with a burden estimated at 197,000 deaths per year in the EU. This has a societal cost of 79 billion per year. Because of this strong impact in public health, regulatory authorities (RAs) worldwide are implementing new pharmacovigilance legislation to promote and protect public health by reducing the burden of ADRs through the detection of safety signals. Although, traditionally, signal detection activities have mainly been performed based on spontaneous reporting from healthcare professionals and national health RAs, the new pharmacovigilance legislation underlines the relevance of other sources of information (such as scientific literature) for the evaluation of the benefit-risk balance of a certain product. This review aims to highlight the relevance of periodic scientific literature screening in the safety signal detection process. The authors present four practical examples where a safety signal that was detected from a literature report had an impact on the lifecycle of a drug. In addition, based on practical experience of the screening of medical and scientific literature for safety purposes, this article analyses the requirements of the new pharmacovigilance guidelines on literature screening and highlights the need for the implementation of a literature review procedure and the main challenges encountered when performing literature screening for safety aspects.

  9. Safety review of conceptual fusion power plants

    Energy Technology Data Exchange (ETDEWEB)

    Clark, R.G.

    1976-11-01

    The potential public safety impacts from accidents in conceptual fusion power plants were investigated. Fusion was found to have some potential for accidents, as does any energy generating system. Functions of fusion power plants were identified that possess sufficient potential for an accidental release of toxic materials to the environment. An assessment was made of the impact of the potential accidents and recommendations are included for R and D that will allow incorporation of safety concerns in fusion power plant design. This work was based on a review of information available in conceptual design documents of fusion reactor systems.

  10. A safety review of medications used for labour induction.

    Science.gov (United States)

    Sheibani, Lili; Wing, Deborah A

    2018-02-01

    Induction of labour is a commonly performed procedure around the world. There are various medications used for induction including those commonly used for cervical ripening (prostaglandins) and oxytocin. The ideal agent is one that decreases the time to achieving delivery without compromising maternal or neonatal safety. The 'optimal safe agent' remains undetermined. Areas covered: This article reviews the safety of currently used induction agents. Prostaglandins and oxytocin have proven to be effective in labour induction, and their profiles will be reviewed in this article. We discuss the data that supports combining some of the agents. We also cover the safety of medications used for labour induction in setting of a scarred uterus. Expert Opinion: There is continuous debate about the ideal induction agent: one that balances safety with efficacy. We recommend the practice that there is not one perfect agent for all, and that the clinical scenario and previous obstetric history should be considered before choosing an agent. In the future, pharmacogenomics may show that genetics may affect the individual response and adverse reactions to the various agents.

  11. NASA Spinoff Article: Automated Procedures To Improve Safety on Oil Rigs

    Science.gov (United States)

    Garud, Sumedha

    2013-01-01

    On May 11th, 2013, two astronauts emerged from the interior of the International Space Station (ISS) and worked their way toward the far end of spacecraft. Over the next 51/2 hours, the two replaced an ammonia pump that had developed a significant leak a few days before. On the ISS, ammonia serves the vital role of cooling components-in this case, one of the station's eight solar arrays. Throughout the extravehicular activity (EVA), the astronauts stayed in constant contact with mission control: every movement, every action strictly followed a carefully planned set of procedures to maximize crew safety and the chances of success. Though the leak had come as a surprise, NASA was prepared to handle it swiftly thanks in part to the thousands of procedures that have been written to cover every aspect of the ISS's operations. The ISS is not unique in this regard: Every NASA mission requires well-written procedures-or detailed lists of step-by-step instructions-that cover how to operate equipment in any scenario, from normal operations to the challenges created by malfunctioning hardware or software. Astronauts and mission control train and drill extensively in procedures to ensure they know what the proper procedures are and when they should be used. These procedures used to be exclusively written on paper, but over the past decade, NASA has transitioned to digital formats. Electronic-based documentation simplifies storage and use, allowing astronauts and flight controllers to find instructions more quickly and display them through a variety of media. Electronic procedures are also a crucial step toward automation: once instructions are digital, procedure display software can be designed to assist in authoring, reviewing, and even executing them.

  12. 77 FR 48112 - Pipeline Safety: Administrative Procedures; Updates and Technical Corrections

    Science.gov (United States)

    2012-08-13

    ... process for pipeline enforcement matters to conform to current law, amends other administrative procedures... and Enforcement Process Maximum administrative civil penalties. Section 2 of the Pipeline Safety Act...-AE29 Pipeline Safety: Administrative Procedures; Updates and Technical Corrections AGENCY: Pipeline and...

  13. Safety of human papillomavirus vaccines: a review

    Science.gov (United States)

    Stillo, Michela; Carrillo Santisteve, Paloma; Lopalco, Pier Luigi

    2015-01-01

    Introduction: Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere. Areas covered: Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed. Expert opinion: Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence. PMID:25689872

  14. TOY SAFETY SURVEILLANCE FROM ONLINE REVIEWS.

    Science.gov (United States)

    Winkler, Matt; Abrahams, Alan S; Gruss, Richard; Ehsani, Johnathan P

    2016-10-01

    Toy-related injuries account for a significant number of childhood injuries and the prevention of these injuries remains a goal for regulatory agencies and manufacturers. Text-mining is an increasingly prevalent method for uncovering the significance of words using big data. This research sets out to determine the effectiveness of text-mining in uncovering potentially dangerous children's toys. We develop a danger word list, also known as a 'smoke word' list, from injury and recall text narratives. We then use the smoke word lists to score over one million Amazon reviews, with the top scores denoting potential safety concerns. We compare the smoke word list to conventional sentiment analysis techniques, in terms of both word overlap and effectiveness. We find that smoke word lists are highly distinct from conventional sentiment dictionaries and provide a statistically significant method for identifying safety concerns in children's toy reviews. Our findings indicate that text-mining is, in fact, an effective method for the surveillance of safety concerns in children's toys and could be a gateway to effective prevention of toy-product-related injuries.

  15. 78 FR 53497 - Uniform Procedures for State Highway Safety Grant Programs

    Science.gov (United States)

    2013-08-29

    ... National Highway Traffic Safety Administration Uniform Procedures for State Highway Safety Grant Programs AGENCY: National Highway Traffic Safety Administration, DOT. ACTION: Request for public comment on... are listed in the http://www.regulations.gov index. Publicly available docket materials are available...

  16. Nitrous oxide provides safe and effective analgesia for minor paediatric procedures - a systematic review

    DEFF Research Database (Denmark)

    Pedersen, Rie S; Bayat, Allan; Steen, Nick Phaff

    2013-01-01

    Pain and distress during minor hospital-related procedures is a familiar problem in many children. Inadequate relief of children's procedural pain and distress not only affects the experience of the children and their parents, but also adversely impacts procedural success. We aimed to review the ...... the safety and efficacy of nitrous oxide during brief, but painful paediatric procedures and to compare nitrous oxide with some of the commonly used pharmacological and non-pharmacological treatments for relieving anxiety and mild to moderate pain in Denmark....

  17. A working procedure for identifying emerging food safety issues at an early stage: Implications for European and international risk management practices

    NARCIS (Netherlands)

    Marvin, H.J.P.; Kleter, G.A.; Frewer, L.J.; Cope, S.F.; Wentholt, M.T.A.; Rowe, G.

    2009-01-01

    There is a need for early identification of emerging food safety issues in order to prevent them from developing into health risks. In this paper, various existing methods and procedures which can be used for early identification of safety issues are reviewed, including the monitoring of the

  18. Packaging review guide for reviewing safety analysis reports for packagings: Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    Fisher, L.E.; Chou, C.K.; Lloyd, W.R.; Mount, M.E.; Nelson, T.A.; Schwartz, M.W.; Witte, M.C.

    1988-10-01

    The Department of Energy (DOE) has established procedures for obtaining certification of packagings used by DOE and its contractors for the transport of radioactive materials. The principal purpose of this document is to assure the quality and uniformity of PCS reviews and to present a well-defined base from which to evaluate proposed changes in the scope and requirements of reviews. The Packaging Review Guide (PRG) also sets forth solutions and approaches determined to be acceptable in the past in dealing with a specific safety issue or safety-related design area. These solutions and approaches are presented in this form so that reviewers can take consistent and well-understood positions as the same safety issues arise in future cases. An applicant submitting a SARP does not have to follow the solutions or approaches presented. It is also a purpose of the PRG to make information about DOE certification policy and procedures widely available to DOE field offices, DOE contractors, federal agencies, and interested members of the public. 77 refs., 16 figs., 15 tabs.

  19. Post Implementation Review Framework and Procedures

    Data.gov (United States)

    Social Security Administration — This template outlines the Social Security Administration's (SSA) approach to initiating, conducting, and completing Post Implementation Reviews (PIRs). The template...

  20. ORIGINAL ARTICLES Safety and efficacy of procedural sedation ...

    African Journals Online (AJOL)

    subsequent development of chronic pain.1-3. Considerable research has proved the safety and efficacy of ... This was a consecutive case series with retrospective evaluation of records of all patients requiring PSA who .... route to the hospital for a painful dislocated shoulder. In this case the combination of alcohol, morphine ...

  1. 49 CFR 214.337 - On-track safety procedures for lone workers.

    Science.gov (United States)

    2010-10-01

    ...: (1) By a lone worker who has been trained, qualified, and designated to do so by the employer in... 49 Transportation 4 2010-10-01 2010-10-01 false On-track safety procedures for lone workers. 214... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection...

  2. Patient safety and electromagnetic protection: a review.

    Science.gov (United States)

    Carranza, Noemí; Febles, Víctor; Hernández, José A; Bardasano, José L; Monteagudo, José L; Fernández de Aldecoa, José C; Ramos, Victoria

    2011-05-01

    A systematic literature review was carried out to study patient security and possible harmful effects, immunity and interferences on medical devices, and effectiveness and transmission problems in healthcare and hospital environments due to electromagnetic interferences. The objective was to determine already-reported cases of patient security, immunity of medical devices, and transmission/reception failure in order to evaluate safety and security of patients. Literature published in the last 10 years has been reviewed by searching in bibliographic databases, journals, and proceedings of conferences. Search strategies developed in electronic databases identified a total of 820 references, with 50 finally being included. The study reveals the existence of numerous publications on interferences in medical devices due to radiofrequency fields. However, literature on effectiveness, transmission problems and measurements of electromagnetic fields is limited. From the studies collected, it can be concluded that several cases of serious interferences in medical instruments have been reported. Measures of electromagnetic fields in healthcare environments have been also reported, concluding that special protective measures should be taken against electromagnetic interferences by incoming radio waves.

  3. Safety Education Impact and Good Practice: A Review

    Science.gov (United States)

    Mulvaney, Caroline A.; Watson, Michael C.; Errington, Gail

    2012-01-01

    Purpose: The aim of this literature review was to examine recent evidence of the impact of safety education for children and young people on unintentional injury rates and to update an earlier review. Evidence was sought that linked safety education for children and young people in schools, centres and other settings with changes in knowledge,…

  4. Conducting organizational safety reviews - requirements, methods and experience

    Energy Technology Data Exchange (ETDEWEB)

    Reiman, T.; Oedewald, P.; Wahlstroem, B. [Technical Research Centre of Finland, VTT (Finland); Rollenhagen, C. [Royal Institute of Technology, KTH, (Sweden); Kahlbom, U. [RiskPilot (Sweden)

    2008-03-15

    Organizational safety reviews are part of the safety management process of power plants. They are typically performed after major reorganizations, significant incidents or according to specified review programs. Organizational reviews can also be a part of a benchmarking between organizations that aims to improve work practices. Thus, they are important instruments in proactive safety management and safety culture. Most methods that have been used for organizational reviews are based more on practical considerations than a sound scientific theory of how various organizational or technical issues influence safety. Review practices and methods also vary considerably. The objective of this research is to promote understanding on approaches used in organizational safety reviews as well as to initiate discussion on criteria and methods of organizational assessment. The research identified a set of issues that need to be taken into account when planning and conducting organizational safety reviews. Examples of the issues are definition of appropriate criteria for evaluation, the expertise needed in the assessment and the organizational motivation for conducting the assessment. The study indicates that organizational safety assessments involve plenty of issues and situations where choices have to be made regarding what is considered valid information and a balance has to be struck between focus on various organizational phenomena. It is very important that these choices are based on a sound theoretical framework and that these choices can later be evaluated together with the assessment findings. The research concludes that at its best, the organizational safety reviews can be utilised as a source of information concerning the changing vulnerabilities and the actual safety performance of the organization. In order to do this, certain basic organizational phenomena and assessment issues have to be acknowledged and considered. The research concludes with recommendations on

  5. Efficacy and safety of uterine manipulators in laparoscopic surgery: a review

    NARCIS (Netherlands)

    Haak, L. van den; Alleblas, C.; Nieboer, T.E.; Rhemrev, J.P.; Jansen, F.W.

    2015-01-01

    PURPOSE: This review aims to objectively assess the efficacy and safety of uterine manipulators as reported in scientific literature. Furthermore, it evaluates as to which manipulator best suits which surgical procedure. METHODS: PubMed, Embase, Web of Science, COCHRANE, CINAHL, Academic Search

  6. Efficacy and safety of uterine manipulators in laparoscopic surgery : A review

    NARCIS (Netherlands)

    Van den Haak, L.; Alleblas, C.; Nieboer, T.E.; Rhemrev, J.P.; Jansen, F.W.

    2015-01-01

    Purpose This review aims to objectively assess the efficacy and safety of uterine manipulators as reported in scientific literature. Furthermore, it evaluates as to which manipulator best suits which surgical procedure. Methods PubMed, Embase, Web of Science, COCHRANE, CINAHL, Academic Search

  7. Review on midurethral sling procedures for stress urinary incontinence

    Directory of Open Access Journals (Sweden)

    Nazura Bt Karim

    2015-05-01

    Full Text Available Minimally invasive suburethral slings, namely the retropubic suburethral sling or the tension-free vaginal tape (TVT, has become the mainstay for surgical management of moderate to severe stress urinary incontinence (SUI taking over the place of Burch's colposuspension after its introduction in the 1990s. Following the introduction of retropubic sling procedures are the transobturator (TVT-O procedures and the mini-sling procedures. This review attempts to summarize the current trend of midurethral sling (MUS procedures in the management of SUI.

  8. 22 CFR 61.7 - Review and appeal procedures.

    Science.gov (United States)

    2010-04-01

    ... Foreign Relations DEPARTMENT OF STATE PUBLIC DIPLOMACY AND EXCHANGES WORLD-WIDE FREE FLOW OF AUDIO-VISUAL MATERIALS § 61.7 Review and appeal procedures. (a) An applicant may request a formal review of any adverse... and any data upon which such argument is based. A copy of the material for which certification or...

  9. Temsirolimus: a safety and efficacy review.

    Science.gov (United States)

    Bukowski, Ronald M

    2012-09-01

    The vascular endothelial growth factor (VEGF) pathway and the mammalian Target of Rapamycin (mTOR) represent the most frequently exploited targets in renal cell carcinoma (RCC). Temsirolimus is an inhibitor of mTOR, and is a unique ester derivative of sirolimus, a macrocyclic lactone, with improved pharmaceutical properties, including stability and solubility. Temsirolimus binds to the cytoplasmic protein FKBP-12, and the complex binds and inhibits mTOR. This review summarizes the clinical findings and safety of temsirolimus in RCC patients. A Phase III clinical trial has demonstrated that temsirolimus has statistically significant advantages over treatment with IFN-α in RCC patients with poor prognosis, in terms of OS (overall survival), PFS (progression-free survival), and tumor response. Median OS was improved 49% compared to IFN-α, and median PFS was approximately doubled. It is now considered the standard for RCC patients with poor prognostic features. The possibility that this agent is useful in metastatic non-clear cell carcinoma patients has also been suggested by a subset analysis of the pivotal Phase III trial. Studies in untreated favorable and intermediate risk clear cell and refractory mRCC patients are required.

  10. Safety testing and operational procedures for self-developed radiofrequency coils.

    Science.gov (United States)

    Hoffmann, Jens; Henning, Anke; Giapitzakis, Ioannis A; Scheffler, Klaus; Shajan, G; Pohmann, Rolf; Avdievich, Nikolai I

    2016-09-01

    The development of novel radiofrequency (RF) coils for human ultrahigh-field (≥7 T), non-proton and body applications is an active field of research in many MR groups. Any RF coil must meet the strict requirements for safe application on humans with respect to mechanical and electrical safety, as well as the specific absorption rate (SAR) limits. For this purpose, regulations such as the International Electrotechnical Commission (IEC) standard for medical electrical equipment, vendor-suggested test specifications for third party coils and custom-developed test procedures exist. However, for higher frequencies and shorter wavelengths in ultrahigh-field MR, the RF fields may become extremely inhomogeneous in biological tissue and the risk of localized areas with elevated power deposition increases, which is usually not considered by existing safety testing and operational procedures. In addition, important aspects, such as risk analysis and comprehensive electrical performance and safety tests, are often neglected. In this article, we describe the guidelines used in our institution for electrical and mechanical safety tests, SAR simulation and verification, risk analysis and operational procedures, including coil documentation, user training and regular quality assurance testing, which help to recognize and eliminate safety issues during coil design and operation. Although the procedure is generally applicable to all field strengths, specific requirements with regard to SAR-related safety and electrical performance at ultrahigh-field are considered. The protocol describes an internal procedure and does not reflect consensus among a large number of research groups, but rather aims to stimulate further discussion related to minimum coil safety standards. Furthermore, it may help other research groups to establish their own procedures. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  11. The Cosmetic Ingredient Review Program-Expert Safety Assessments of Cosmetic Ingredients in an Open Forum.

    Science.gov (United States)

    Boyer, Ivan J; Bergfeld, Wilma F; Heldreth, Bart; Fiume, Monice M; Gill, Lillian J

    The Cosmetic Ingredient Review (CIR) is a nonprofit program to assess the safety of ingredients in personal care products in an open, unbiased, and expert manner. Cosmetic Ingredient Review was established in 1976 by the Personal Care Products Council (PCPC), with the support of the US Food and Drug Administration (USFDA) and the Consumer Federation of America (CFA). Cosmetic Ingredient Review remains the only scientific program in the world committed to the systematic, independent review of cosmetic ingredient safety in a public forum. Cosmetic Ingredient Review operates in accordance with procedures modeled after the USFDA process for reviewing over-the-counter drugs. Nine voting panel members are distinguished, such as medical professionals, scientists, and professors. Three nonvoting liaisons are designated by the USFDA, CFA, and PCPC to represent government, consumer, and industry, respectively. The annual rate of completing safety assessments accelerated from about 100 to more than 400 ingredients by implementing grouping and read-across strategies and other approaches. As of March 2017, CIR had reviewed 4,740 individual cosmetic ingredients, including 4,611 determined to be safe as used or safe with qualifications, 12 determined to be unsafe, and 117 ingredients for which the information is insufficient to determine safety. Examples of especially challenging safety assessments and issues are presented here, including botanicals. Cosmetic Ingredient Review continues to strengthen its program with the ongoing cooperation of the USFDA, CFA, the cosmetics industry, and everyone else interested in contributing to the process.

  12. Nitrous oxide provides safe and effective analgesia for minor paediatric procedures--a systematic review.

    Science.gov (United States)

    Pedersen, Rie S; Bayat, Allan; Steen, Nick Phaff; Jacobsson, Marie-Laure Bouchy

    2013-06-01

    Pain and distress during minor hospital-related procedures is a familiar problem in many children. Inadequate relief of children's procedural pain and distress not only affects the experience of the children and their parents, but also adversely impacts procedural success. We aimed to review the safety and efficacy of nitrous oxide during brief, but painful paediatric procedures and to compare nitrous oxide with some of the commonly used pharmacological and non-pharmacological treatments for relieving anxiety and mild to moderate pain in Denmark. We searched MEDLINE (PubMed) and the Cochrane Database of Systematic Reviews with the MeSH term nitrous oxide combined with midazolam, surgical procedures minor, analgesia or conscious sedation. The references in the articles acquired that were not found in the MEDLINE search were further investigated. Only articles written in English and published after 1980 were included to ensure optimal data collection. Nitrous oxide is an effective sedative/analgesic for mildly to moderately painful paediatric procedures. Furthermore, it is safely administrated, particularly for short procedures (Nitrous oxide is a safe and effective method to achieve analgesia and sedation during minor, but painful procedures. It can be safely administered by a dedicated staff member. This helpful method is still underused in Denmark, and we believe that it could be an alternative or the first choice of treatment in emergency and paediatric departments.

  13. Design review report for modifications to RMCS safety class equipment

    Energy Technology Data Exchange (ETDEWEB)

    Corbett, J.E.

    1997-05-30

    This report documents the completion of the formal design review for modifications to the Rotary Mode Core Sampling (RMCS) safety class equipment. These modifications are intended to support core sampling operations in waste tanks requiring flammable gas controls. The objective of this review was to approve the Engineering Change Notices affecting safety class equipment used in the RMCS system. The conclusion reached by the review committee was that these changes are acceptable.

  14. Second periodic safety review of Angra Nuclear Power Station, unit 1

    Energy Technology Data Exchange (ETDEWEB)

    Martins, Carlos F.O.; Crepaldi, Roberto; Freire, Enio M., E-mail: ottoncf@tecnatom.com.br, E-mail: emfreire46@gmail.com, E-mail: robcrepaldi@hotmail.com [Tecnatom do Brasil Engenharia e Servicos Ltda, Rio de Janeiro, RJ (Brazil); Campello, Sergio A., E-mail: sacampe@eletronuclear.gov.br [Eletrobras Termonuclear S.A. (ELETRONUCLEAR), Rio de Janeiro, RJ (Brazil)

    2015-07-01

    This paper describes the second Periodic Safety Review (PSR2-A1) of Angra Nuclear Power Station, Unit 1, prepared by Eletrobras Eletronuclear S.A. and Tecnatom do Brasil Engenharia e Servicos Ltda., during Jul.2013-Aug.2014, covering the period of 2004-2013. The site, in Angra dos Reis-RJ, Brazil, comprises: Unit 1, (640 MWe, Westinghouse PWR, operating), Unit 2 (1300 MWe, KWU/Areva, operating) and Unit 3 (1405 MWe, KWU/Areva, construction). The PSR2-A1 attends the Standards 1.26-Safety in Operation of Nuclear Power Plants, Brazilian Nuclear Regulatory Commission (CNEN), and IAEA.SSG.25-Periodic Safety Review of Nuclear Power Plants. Within 18 months after each 10 years operation, the operating organization shall perform a plant safety review, to investigate the evolution consequences of safety code and standards, regarding: Plant design; structure, systems and components behavior; equipment qualification; plant ageing management; deterministic and probabilistic safety analysis; risk analysis; safety performance; operating experience; organization and administration; procedures; human factors; emergency planning; radiation protection and environmental radiological impacts. The Review included 6 Areas and 14 Safety Parameters, covered by 33 Evaluations.After document evaluations and discussions with plant staff, it was generated one General and 33 Specific Guide Procedures, 33 Specific and one Final Report, including: Description, Strengths, Deficiencies, Areas for Improvement and Conclusions. An Action Plan was prepared by Electronuclear for the recommendations. It was concluded that the Unit was operated within safety standards and will attend its designed operational lifetime, including possible life extensions. The Final Report was submitted to CNEN, as one requisite for renewal of the Unit Permanent Operation License. (author)

  15. Nonsurgical Facial Rejuvenation: Outcomes and Safety of Neuromodulator and Soft-Tissue Filler Procedures Performed in a Resident Cosmetic Clinic.

    Science.gov (United States)

    Qureshi, Ali A; Parikh, Rajiv P; Sharma, Ketan; Myckatyn, Terence M; Tenenbaum, Marissa M

    2017-10-01

    The ability to perform nonsurgical facial rejuvenation procedures is a core competency requirement for plastic surgery residents. However, limited data exist on training models to achieve competency in nonsurgical facial rejuvenation and on outcomes of these procedures performed by residents. The purpose here is to evaluate patient-reported outcomes and safety of nonsurgical facial rejuvenation procedures performed by plastic surgery residents. We prospectively enrolled 50 patients undergoing neuromodulator and/or soft-tissue filler injections in a resident cosmetic clinic between April and August 2016. Patients completed FACE-Q modules pre-procedure, and at 1 week and 1 month post-procedure. Paired t-tests were used to calculate statistical significance of changes between pre- and post-procedure scores. Effect sizes were calculated to assess clinical improvement from pre- to post-procedure. The magnitude of change was interpreted using Cohen's arbitrary criteria (small 0.20, moderate 0.50, large 0.80). Forty-five patients completed the study. Patients experienced significant improvements (p Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors http://www.springer.com/00266 .

  16. Standard Review Plan Update and Development Program. Implementing Procedures Document

    Energy Technology Data Exchange (ETDEWEB)

    1992-05-01

    This implementing procedures document (IPD) was prepared for use in implementing tasks under the standard review plan update and development program (SRP-UDP). The IPD provides comprehensive guidance and detailed procedures for SRP-UDP tasks. The IPD is mandatory for contractors performing work for the SRP-UDP. It is guidance for the staff. At the completion of the SRP-UDP, the IPD will be revised (to remove the UDP aspects) and will replace NRR Office Letter No. 800 as long-term maintenance procedures.

  17. Standard Review Plan Maintenance Program implementing procedures document

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-11-01

    The implementing Procedures Document (IPD) was developed by the Inspection Program Projects Branch, Office of Nuclear Reactor Regulation, with assistance from Pacific Northwest National Laboratory, for the Standard Review Plan Maintenance Program (SRP-MP). The SRP-MP was established to maintain the Standard Review Plan (SRP) on an on-going basis. The IPD provides guidance, including an overall approach and procedures, for SRP-MP tasks. The objective of the IPD is to ensure that modifications to SRP need to reflect current NRC requirements and guidance are identified and that a consistent methodology is used to develop and revise SRP sections.

  18. Tank waste remediation system nuclear criticality safety program management review

    Energy Technology Data Exchange (ETDEWEB)

    BRADY RAAP, M.C.

    1999-06-24

    This document provides the results of an internal management review of the Tank Waste Remediation System (TWRS) criticality safety program, performed in advance of the DOE/RL assessment for closure of the TWRS Nuclear Criticality Safety Issue, March 1994. Resolution of the safety issue was identified as Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) Milestone M-40-12, due September 1999.

  19. Nuclear Safety: Technical progress review, January--March 1989

    Energy Technology Data Exchange (ETDEWEB)

    Silver, E. G. [ed.

    1989-01-01

    This review journal covers significant developments in the field of nuclear safety. Its scope includes the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials, and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated.

  20. Patient safety in otolaryngology: a descriptive review.

    Science.gov (United States)

    Danino, Julian; Muzaffar, Jameel; Metcalfe, Chris; Coulson, Chris

    2017-03-01

    Human evaluation and judgement may include errors that can have disastrous results. Within medicine and healthcare there has been slow progress towards major changes in safety. Healthcare lags behind other specialised industries, such as aviation and nuclear power, where there have been significant improvements in overall safety, especially in reducing risk of errors. Following several high profile cases in the USA during the 1990s, a report titled "To Err Is Human: Building a Safer Health System" was published. The report extrapolated that in the USA approximately 50,000 to 100,000 patients may die each year as a result of medical errors. Traditionally otolaryngology has always been regarded as a "safe specialty". A study in the USA in 2004 inferred that there may be 2600 cases of major morbidity and 165 deaths within the specialty. MEDLINE via PubMed interface was searched for English language articles published between 2000 and 2012. Each combined two or three of the keywords noted earlier. Limitations are related to several generic topics within patient safety in otolaryngology. Other areas covered have been current relevant topics due to recent interest or new advances in technology. There has been a heightened awareness within the healthcare community of patient safety; it has become a major priority. Focus has shifted from apportioning blame to prevention of the errors and implementation of patient safety mechanisms in healthcare delivery. Type of Errors can be divided into errors due to action and errors due to knowledge or planning. In healthcare there are several factors that may influence adverse events and patient safety. Although technology may improve patient safety, it also introduces new sources of error. The ability to work with people allows for the increase in safety netting. Team working has been shown to have a beneficial effect on patient safety. Any field of work involving human decision-making will always have a risk of error. Within

  1. 78 FR 11902 - Review of Gun Safety Technologies

    Science.gov (United States)

    2013-02-20

    ... an interest in gun safety. Representative stakeholders include, but are not limited to, law... of Justice Programs Review of Gun Safety Technologies AGENCY: National Institute of Justice, JPO, DOJ. ACTION: Notice. SUMMARY: Following the President's Plan to reduce gun violence released on January 16...

  2. A combined deterministic and probabilistic procedure for safety assessment of components with cracks - Handbook.

    Energy Technology Data Exchange (ETDEWEB)

    Dillstroem, Peter; Bergman, Mats; Brickstad, Bjoern; Weilin Zang; Sattari-Far, Iradj; Andersson, Peder; Sund, Goeran; Dahlberg, Lars; Nilsson, Fred (Inspecta Technology AB, Stockholm (Sweden))

    2008-07-01

    SSM has supported research work for the further development of a previously developed procedure/handbook (SKI Report 99:49) for assessment of detected cracks and tolerance for defect analysis. During the operative use of the handbook it was identified needs to update the deterministic part of the procedure and to introduce a new probabilistic flaw evaluation procedure. Another identified need was a better description of the theoretical basis to the computer program. The principal aim of the project has been to update the deterministic part of the recently developed procedure and to introduce a new probabilistic flaw evaluation procedure. Other objectives of the project have been to validate the conservatism of the procedure, make the procedure well defined and easy to use and make the handbook that documents the procedure as complete as possible. The procedure/handbook and computer program ProSACC, Probabilistic Safety Assessment of Components with Cracks, has been extensively revised within this project. The major differences compared to the last revision are within the following areas: It is now possible to deal with a combination of deterministic and probabilistic data. It is possible to include J-controlled stable crack growth. The appendices on material data to be used for nuclear applications and on residual stresses are revised. A new deterministic safety evaluation system is included. The conservatism in the method for evaluation of the secondary stresses for ductile materials is reduced. A new geometry, a circular bar with a circumferential surface crack has been introduced. The results of this project will be of use to SSM in safety assessments of components with cracks and in assessments of the interval between the inspections of components in nuclear power plants

  3. 15 CFR 923.82 - Amendment review/approval procedures.

    Science.gov (United States)

    2010-01-01

    ... National Environmental Policy Act of 1969, as amended, whether an environmental impact statement (EIS) is... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Amendment review/approval procedures. 923.82 Section 923.82 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade...

  4. Defining and Measuring Safety Climate: A Review of the Construction Industry Literature.

    Science.gov (United States)

    Schwatka, Natalie V; Hecker, Steven; Goldenhar, Linda M

    2016-06-01

    Safety climate measurements can be used to proactively assess an organization's effectiveness in identifying and remediating work-related hazards, thereby reducing or preventing work-related ill health and injury. This review article focuses on construction-specific articles that developed and/or measured safety climate, assessed safety climate's relationship with other safety and health performance indicators, and/or used safety climate measures to evaluate interventions targeting one or more indicators of safety climate. Fifty-six articles met our inclusion criteria, 80% of which were published after 2008. Our findings demonstrate that researchers commonly defined safety climate as perception based, but the object of those perceptions varies widely. Within the wide range of indicators used to measure safety climate, safety policies, procedures, and practices were the most common, followed by general management commitment to safety. The most frequently used indicators should and do reflect that the prevention of work-related ill health and injury depends on both organizational and employee actions. Safety climate scores were commonly compared between groups (e.g. management and workers, different trades), and often correlated with subjective measures of safety behavior rather than measures of ill health or objective safety and health outcomes. Despite the observed limitations of current research, safety climate has been promised as a useful feature of research and practice activities to prevent work-related ill health and injury. Safety climate survey data can reveal gaps between management and employee perceptions, or between espoused and enacted policies, and trigger communication and action to narrow those gaps. The validation of safety climate with safety and health performance data offers the potential for using safety climate measures as a leading indicator of performance. We discuss these findings in relation to the related concept of safety culture and

  5. Nulcear Safety: Technical progress review, October--December 1988

    Energy Technology Data Exchange (ETDEWEB)

    Silver, E G [ed.

    1988-01-01

    Nuclear Safety is a review journal that covers significant developments in the field of nuclear safety. Its scope includes the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials, and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated.

  6. Nuclear Safety: Volume 29, No. 3: Technical progress review

    Energy Technology Data Exchange (ETDEWEB)

    Silver, E G [ed.

    1988-07-01

    Nuclear Safety is a review journal that covers significant development in the field of nuclear safety. Its scope included the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated. Individual papers have been cataloged separately.

  7. Improving the review of standard operating procedures: a novel electronic system for compounding pharmacies.

    Science.gov (United States)

    Brensel, Robert; Brensel, Scott; Ng, Amy

    2013-01-01

    Since the New England Compounding Center disaster in 2012, the importance of following correct procedures during every phase of customized pharmacy has been a focus of governmental interest and action as well as public scrutiny. Many pharmacies rely on the rote review of standard operating procedures to ensure that staff members understand and follow protocols that ensure the safety and potency of all compounds prepared, but that approach to continuing education can be cumbersome and needlessly time-consuming. In addition, documenting and retrieving evidence of employee competence can be difficult. In this article, we describe our use of online technology to improve our methods of educating staff about the full range of standard operating procedures that must be followed in our pharmacy. The system we devised and implemented has proven to be effective, easy to update and maintain, very inexpensive, and user friendly. Its use has reduced the time previously required for a read-over review of standard operating procedures from 30 or 40 minutes to 5 or 10 minutes in weekly staff meetings, and we can now easily document and access proof of employees' comprehension of that content. It is our hope that other small compounding pharmacies will also find this system of online standard operating procedure review helpful.

  8. Evaluation of Policy Implementation at Norm Strategy Criteria Procedure Safety Management System that Influence the Safety Culture in Building Construction, Housing, Waterworks, Road and Bridge Project in Indonesia

    OpenAIRE

    Yusuf Latief; Rossy Armyn Machfudiyanto; Brain Harryanto; Cahyadi Santoso

    2017-01-01

    Unideal Safety culture in Indonesia requires an evaluation of policy implementation refers to the construction safety regulation, Ministry Regulation 05/PRT/2014. Out of Norms, Standards, Procedures and Criteria (NSPK), we only have Norms and Procedure. As for Standard and Criteria are still being planned. This research on building, housing, water resource, roads and bridges construction at the Ministry of General Works and Housing resulted in having significant relation between safety policy...

  9. [Should we establish patient safety leadership walkrounds? A systematic review].

    Science.gov (United States)

    Girerd-Genessay, I; Michel, P

    2015-10-01

    Used for over a decade, patient safety leadership walkrounds (PSLWs) is a managerial method designed to enhance the implementation of safety measures in hospitals. In order to determine the effect of PSLWs in French hospitals, we reviewed the literature on participant perceptions and the impact of PSLW on the overall culture of safety. We conducted a systematic review of articles assessing the impact of PSLWs on the culture of safety (comparative studies) or the perceptions of caregivers and managers (qualitative studies). Five studies investigating safety culture and three studies investigating participant perception were identified. PSLWs were associated with an improvement in safety culture and the overall safety climate. The presence of caregivers during the PSLWs was important to achieve improvement. PSLWs improved the dialogue between caregivers and managers, and improved knowledge on care safety. Some problems concerning managerial PSLW attendance and counter-productive attitudes have occasionally been reported. PSLWs improve safety culture. Their effectiveness depends on the way they are implemented. They should initially be tested in France to ensure their feasibility and acceptability in our healthcare system. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  10. A review of the safety aspects of radio frequency ablation

    Directory of Open Access Journals (Sweden)

    Abhishek Bhaskaran

    2015-09-01

    Full Text Available In light of recent reports showing high incidence of silent cerebral infarcts and organized atrial arrhythmias following radiofrequency (RF atrial fibrillation (AF ablation, a review of its safety aspects is timely. Serious complications do occur during supraventricular tachycardia (SVT ablations and knowledge of their incidence is important when deciding whether to proceed with ablation. Evidence is emerging for the probable role of prophylactic ischemic scar ablation to prevent VT. This might increase the number of procedures performed. Here we look at the various complications of RF ablation and also the methods to minimize them. Electronic database was searched for relevant articles from 1990 to 2015. With better awareness and technological advancements in RF ablation the incidence of complications has improved considerably. In AF ablation it has decreased from 6% to less than 4% comprising of vascular complications, cardiac tamponade, stroke, phrenic nerve injury, pulmonary vein stenosis, atrio-esophageal fistula (AEF and death. Safety of SVT ablation has also improved with less than 1% incidence of AV node injury in AVNRT ablation. In VT ablation the incidence of major complications was 5–11%, up to 3.4%, up to 1.8% and 4.1–8.8% in patients with structural heart disease, without structural heart disease, prophylactic ablations and epicardial ablations respectively. Vascular and pericardial complications dominated endocardial and epicardial VT ablations respectively. Up to 3% mortality and similar rates of tamponade were reported in endocardial VT ablation. Recent reports about the high incidence of asymptomatic cerebral embolism during AF ablation are concerning, warranting more research into its etiology and prevention.

  11. Improving the safety and quality of nursing care through standardized operating procedures in Bosnia and Herzegovina.

    Science.gov (United States)

    Ausserhofer, Dietmar; Rakic, Severin; Novo, Ahmed; Dropic, Emira; Fisekovic, Eldin; Sredic, Ana; Van Malderen, Greet

    2016-06-01

    We explored how selected 'positive deviant' healthcare facilities in Bosnia and Herzegovina approach the continuous development, adaptation, implementation, monitoring and evaluation of nursing-related standard operating procedures. Standardized nursing care is internationally recognized as a critical element of safe, high-quality health care; yet very little research has examined one of its key instruments: nursing-related standard operating procedures. Despite variability in Bosnia and Herzegovina's healthcare and nursing care quality, we assumed that some healthcare facilities would have developed effective strategies to elevate nursing quality and safety through the use of standard operating procedures. Guided by the 'positive deviance' approach, we used a multiple-case study design to examine a criterion sample of four facilities (two primary healthcare centres and two hospitals), collecting data via focus groups and individual interviews. In each studied facility, certification/accreditation processes were crucial to the initiation of continuous development, adaptation, implementation, monitoring and evaluation of nursing-related SOPs. In one hospital and one primary healthcare centre, nurses working in advanced roles (i.e. quality coordinators) were responsible for developing and implementing nursing-related standard operating procedures. Across the four studied institutions, we identified a consistent approach to standard operating procedures-related processes. The certification/accreditation process is enabling necessary changes in institutions' organizational cultures, empowering nurses to take on advanced roles in improving the safety and quality of nursing care. Standardizing nursing procedures is key to improve the safety and quality of nursing care. Nursing and Health Policy are needed in Bosnia and Herzegovina to establish a functioning institutional framework, including regulatory bodies, educational systems for developing nurses' capacities or the

  12. Occupational Health and Safety in Ethiopia: A review of Situational ...

    African Journals Online (AJOL)

    kim

    2Pesticide Action Network (PAN) Nexus, Ethiopia;. 3Department of Preventive Medicine, Keck School of Medicine, University of Southern California, USA;. 4Ministry of Labour and Social Affairs, Ethiopia. Review Article. Occupational Health and Safety in Ethiopia: A review of. Situational Analysis and Needs Assessment.

  13. Evaluating North Carolina Food Pantry Food Safety-Related Operating Procedures.

    Science.gov (United States)

    Chaifetz, Ashley; Chapman, Benjamin

    2015-11-01

    Almost one in seven American households were food insecure in 2012, experiencing difficulty in providing enough food for all family members due to a lack of resources. Food pantries assist a food-insecure population through emergency food provision, but there is a paucity of information on the food safety-related operating procedures used in the pantries. Food pantries operate in a variable regulatory landscape; in some jurisdictions, they are treated equivalent to restaurants, while in others, they operate outside of inspection regimes. By using a mixed methods approach to catalog the standard operating procedures related to food in 105 food pantries from 12 North Carolina counties, we evaluated their potential impact on food safety. Data collected through interviews with pantry managers were supplemented with observed food safety practices scored against a modified version of the North Carolina Food Establishment Inspection Report. Pantries partnered with organized food bank networks were compared with those that operated independently. In this exploratory research, additional comparisons were examined for pantries in metropolitan areas versus nonmetropolitan areas and pantries with managers who had received food safety training versus managers who had not. The results provide a snapshot of how North Carolina food pantries operate and document risk mitigation strategies for foodborne illness for the vulnerable populations they serve. Data analysis reveals gaps in food safety knowledge and practice, indicating that pantries would benefit from more effective food safety training, especially focusing on formalizing risk management strategies. In addition, new tools, procedures, or policy interventions might improve information actualization by food pantry personnel.

  14. Safety of nanofood: A review | Ijabadeniyi | African Journal of ...

    African Journals Online (AJOL)

    Introduction of genetically modified (GM) foods generated a lot of controversy few years back, now it is the turn of nanofoods. There has been debate on the safety of foods that have been produced directly or indirectly with nanomaterials. Nanoparticles or nanotechnology procedures may be used to make food products, ...

  15. Advanced human-system interface design review guideline. Evaluation procedures and guidelines for human factors engineering reviews

    Energy Technology Data Exchange (ETDEWEB)

    O`Hara, J.M.; Brown, W.S. [Brookhaven National Lab., Upton, NY (United States); Baker, C.C.; Welch, D.L.; Granda, T.M.; Vingelis, P.J. [Carlow International Inc., Falls Church, VA (United States)

    1994-07-01

    Advanced control rooms will use advanced human-system interface (HSI) technologies that may have significant implications for plant safety in that they will affect the operator`s overall role in the system, the method of information presentation, and the ways in which operators interact with the system. The U.S. Nuclear Regulatory Commission (NRC) reviews the HSI aspects of control rooms to ensure that they are designed to good human factors engineering principles and that operator performance and reliability are appropriately supported to protect public health and safety. The principal guidance available to the NRC, however, was developed more than ten years ago, well before these technological changes. Accordingly, the human factors guidance needs to be updated to serve as the basis for NRC review of these advanced designs. The purpose of this project was to develop a general approach to advanced HSI review and the human factors guidelines to support. NRC safety reviews of advanced systems. This two-volume report provides the results of the project. Volume I describes the development of the Advanced HSI Design Review Guideline (DRG) including (1) its theoretical and technical foundation, (2) a general model for the review of advanced HSIs, (3) guideline development in both hard-copy and computer-based versions, and (4) the tests and evaluations performed to develop and validate the DRG. Volume I also includes a discussion of the gaps in available guidance and a methodology for addressing them. Volume 2 provides the guidelines to be used for advanced HSI review and the procedures for their use.

  16. A review of microwave oven safety.

    Science.gov (United States)

    Osepchuk, J M

    1978-03-01

    The microwave leakage from current microwave ovens, which are manufactured to meet government emission standards, is reviewed. Typical leakage values imply exposure values well below the most conservative exposure standards in the world. A review of recent developments discloses increasingly stringent government regulation along with advances in techniques for suppression of microwave leakage. The nature of the leakage field is described and studies relating emission to exposure are reviewed. Field survey data are reviewed and it is found that the overwhelming majority of certified ovens in the field show leakage well below permissible limits with an increasing degree of certainty as time goes on. The conclusion is that microwave ovens are not only just as safe as they were in 1973 but they are being accepted as safe under essentially equivalent emission regulations in various countries including those in Eastern Europe.

  17. Review and Application of Ship Collision and Grounding Analysis Procedures

    DEFF Research Database (Denmark)

    Pedersen, Preben Terndrup

    2010-01-01

    It is the purpose of the paper to present a review of prediction and analysis tools for collision and grounding analyses and to outline a probabilistic procedure for which these tools can be used by the maritime industry to develop performance based rules to reduce the risk associated with human,......, environmental and economic costs of collision and grounding events. The main goal of collision and grounding research should be to identify the most economic risk control options associated with prevention and mitigation of collision and grounding events.......It is the purpose of the paper to present a review of prediction and analysis tools for collision and grounding analyses and to outline a probabilistic procedure for which these tools can be used by the maritime industry to develop performance based rules to reduce the risk associated with human...

  18. Achievements and challenges of Space Station Freedom's safety review process

    Science.gov (United States)

    Robinson, David W.

    1993-01-01

    The most complex space vehicle in history, Space Station Freedom, is well underway to completion, and System Safety is a vital part of the program. The purpose is to summarize and illustrate the progress that over one-hundred System Safety engineers have made in identifying, documenting, and controlling the hazards inherent in the space station. To date, Space Station Freedom has been reviewed by NASA's safety panels through the first six assembly flights, when Freedom achieves a configuration known as Man Tended Capability. During the eight weeks of safety reviews spread out over a year and a half, over 200 preliminary hazard reports were presented. Along the way NASA and its contractors faced many challenges, made much progress, and even learned a few lessons.

  19. Effectiveness of granite cleaning procedures in cultural heritage: A review.

    Science.gov (United States)

    Pozo-Antonio, J S; Rivas, T; López, A J; Fiorucci, M P; Ramil, A

    2016-11-15

    Most of the Cultural Heritage built in NW Iberian Peninsula is made of granite which exposition to the environment leads to the formation of deposits and coatings, mainly two types: biological colonization and sulphated black crusts. Nowadays, another form of alteration derives from graffiti paints when these are applied as an act of vandalism. A deep revision needs to be addressed considering the severity of these deterioration forms on granite and the different cleaning effectiveness achieved by cleaning procedures used to remove them. The scientific literature about these topics on granite is scarcer than on sedimentary carbonate stones and marbles, but the importance of the granite in NW Iberian Peninsula Cultural Heritage claims this review centred on biological colonization, sulphated black crusts and graffiti on granite and their effectiveness of the common cleaning procedures. Furthermore, this paper carried out a review of the knowledge about those three alteration forms on granite, as well as bringing together all the major studies in the field of the granite cleaning with traditional procedures (chemical and mechanical) and with the recent developed technique based on the laser ablation. Findings concerning the effectiveness evaluation of these cleaning procedures, considering the coating extraction ability and the damage induced on the granite surface, are described. Finally, some futures research lines are pointed out. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Token Economy: A Systematic Review of Procedural Descriptions.

    Science.gov (United States)

    Ivy, Jonathan W; Meindl, James N; Overley, Eric; Robson, Kristen M

    2017-09-01

    The token economy is a well-established and widely used behavioral intervention. A token economy is comprised of six procedural components: the target response(s), a token that functions as a conditioned reinforcer, backup reinforcers, and three interconnected schedules of reinforcement. Despite decades of applied research, the extent to which the procedures of a token economy are described in complete and replicable detail has not been evaluated. Given the inherent complexity of a token economy, an analysis of the procedural descriptions may benefit future token economy research and practice. Articles published between 2000 and 2015 that included implementation of a token economy within an applied setting were identified and reviewed with a focus on evaluating the thoroughness of procedural descriptions. The results show that token economy components are regularly omitted or described in vague terms. Of the articles included in this analysis, only 19% (18 of 96 articles reviewed) included replicable and complete descriptions of all primary components. Missing or vague component descriptions could negatively affect future research or applied practice. Recommendations are provided to improve component descriptions.

  1. Review of actinide nitride properties with focus on safety aspects

    Energy Technology Data Exchange (ETDEWEB)

    Albiol, Thierry [CEA Cadarache, St Paul Lez Durance Cedex (France); Arai, Yasuo [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    2001-12-01

    This report provides a review of the potential advantages of using actinide nitrides as fuels and/or targets for nuclear waste transmutation. Then a summary of available properties of actinide nitrides is given. Results from irradiation experiments are reviewed and safety relevant aspects of nitride fuels are discussed, including design basis accidents (transients) and severe (core disruptive) accidents. Anyway, as rather few safety studies are currently available and as many basic physical data are still missing for some actinide nitrides, complementary studies are proposed. (author)

  2. 78 FR 4477 - Review of Safety Analysis Reports for Nuclear Power Plants, Introduction

    Science.gov (United States)

    2013-01-22

    ... COMMISSION Review of Safety Analysis Reports for Nuclear Power Plants, Introduction AGENCY: Nuclear... subsection to NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power..., Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: Integral...

  3. Implementation of a Modified WHO Pediatric Procedural Sedation Safety Checklist and Its Impact on Risk Reduction.

    Science.gov (United States)

    Kahlenberg, Lindsay; Harsey, Lindsay; Patterson, Mary; Wachsberger, Don; Gothard, Dave; Holder, Michael; Forbes, Michael; Tirodker, Urmila

    2017-04-01

    Major adverse events (AEs) related to pediatric deep sedation occur at a low frequency but can be of high acuity. The high volume of deep sedations performed by 3 departments at our institution provided an opportunity to reduce variability and increase safety through implementation of a procedural sedation safety checklist. We hypothesized that implementation of a checklist would improve compliance of critical safety elements (CSEs) (primary outcome variable) and reduce the sedation-related AE rate (secondary outcome variable). This process improvement project was divided into 5 phases: a retrospective analysis to assess variability in capture of CSE within 3 departments that perform deep sedation and the association between noncapture of CSE and AE occurrence (phase 1), design of the checklist and trial in simulation (phase 2), provider education (phase 3), implementation and interim analysis of checklist completion (phase 4), and final analysis of completion and impact on outcome (phase 5). We demonstrated interdepartmental variability in compliance with CSE completion prechecklist implementation, and we identified elements associated with AEs. Completion of provider education was 100% in all 3 departments. Final analysis showed a checklist completion rate of 75%, and its use significantly improved capture of several critical safety elements. Its use did not significantly reduce AEs (P = .105). This study demonstrates that the implementation of a sedation checklist improved process adherence and capture of critical safety elements; however, it failed to show a significant reduction in sedation-related AEs. Copyright © 2017 by the American Academy of Pediatrics.

  4. Book review: Safety of Biologics Therapy

    Directory of Open Access Journals (Sweden)

    Robak T

    2017-01-01

    Full Text Available Tadeusz Robak Department of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, PolandSafety of Biologics Therapy: Monoclonal Antibodies, Cytokines, Fusion Proteins, Hormones, Enzymes, Coagulation Proteins, Vaccines, Botulinum Toxins (Cham, Switzerland: Springer International Publishing; 2016 by Brian A Baldo from the Molecular Immunology Unit, Kolling Institute of Medical Research, Royal North Shore Hospital of Sydney, and the Department of Medicine, University of Sydney, Australia, is a book that belongs on the shelf of everyone in the field of biologic therapies research and clinical practice. In writing this book, the author’s intention was to produce an up-to-date text book on approved biologic therapies, as far as that is possible in this time of rapidly evolving developments in biotherapeutic research and the introduction of new and novel agents for clinical use.The monograph comprises 610 pages in 13 chapters, each including a summary and further reading suggestions. All chapters include a discussion of basic and clinical material. Well-designed, comprehensive tables and color figures are present throughout the book. The book itself examines the biologic products that have regulatory approval in the USA and/or European Union and that show every indication of remaining important therapies. It covers in great detail all the latest work on peptide hormones and enzymes, monoclonal antibodies, fusion proteins, and cytokine therapies. Beyond that, it also presents the latest information on blood coagulation proteins, vaccines, botulinum neurotoxins, and biosimilars. 

  5. Human Factors Evaluation of Man-Machine Interface for Periodic Safety Review of Yonggwang Unit no. 1, 2

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Yong Hee; Lee, Jung Woon; Park, Jae Chang (and others)

    2006-01-15

    This report describes the research results of human factors assessment on the MMI(Man Machine Interface) equipment as part of Periodic Safety Review(PSR) of Yonggwang Unit no. 1, 2. As MMI is a key factor among human factors to be reviewed in PSR, we reviewed the MMI components of nuclear power plants in aspect of human factors engineering. The availability, suitability, and effectiveness of the MMI devices were chosen to be reviewed. The MMI devices were investigated through the review of design documents related to the MMI, survey of control panels, evaluation of experts, and experimental assessment. Checklists were used to perform this assessment and record the review results. The items mentioned by the expert comments to review in detail in relation with task procedures were tested by experiments with operators' participation. For some questionable issues arisen during this MMI review, operator workload and possibility of errors in operator actions were analysed. The reviewed MMI devices contain MCR(Main Control Room), SPDS(Safety Parameter Display System), RSP(Remote Shutdown Panel), and the selected LCBs(Local Control Boards) importantly related to safety. As results of the assessments, any significant problem challenging the safety was not found on human factors in the MMI devices. However, several small items to be changed and improved in suitability of MMI devices were discovered. An action plan is recommended to accommodate the suggestions and review comments. It will enhance the plant safety on MMI area.

  6. CT sizing for left atrial appendage closure is associated with favourable outcomes for procedural safety.

    Science.gov (United States)

    Rajwani, Adil; Nelson, Adam J; Shirazi, Masoumeh G; Disney, Patrick J S; Teo, Karen S L; Wong, Dennis T L; Young, Glenn D; Worthley, Stephen G

    2017-12-01

    We evaluated the utility of computerized tomography (CT) with respect to sizing work-up for percutaneous left atrial appendage (LAA) closure, and implications for procedural safety and outcomes. Contrast-enhanced multi-detector CT was routinely conducted to guide sizing for LAA closure in addition to transoesophageal echocardiography (TOE). Procedural safety and efficacy were prospectively assessed. Across 73 consecutive cases there were no device-related procedural complications, and no severe leaks. Systematic bias in orifice sizing by TOE vs. CT was significant on retrospective analysis (bias -3.0 mm vs. maximum diameter on CT; bias -1.1 mm vs. mean diameter on CT). Importantly, this translated to an altered device size selection in more than half of all cases, and median size predicted by CT was one interval greater than that predicted by TOE (27 mm vs. 24 mm). Of particular note, gross sizing error by TOE vs. CT was observed in at least 3.4% of cases. Degree of discrepancy between TOE and CT was correlated with LAA orifice eccentricity, orifice size, and left atrial volume. Mean orifice size by CT had the greatest utility for final Watchman device-size selection. In this single-centre registry of LAA closure, routine incorporation of CT was associated with excellent outcomes for procedural safety and absence of major residual leak. Mean orifice size may be preferable to maximum orifice size. A particular value of CT may be the detection and subsequent avoidance of gross sizing error by 2D TOE that occurs in a small but important proportion of cases.

  7. Improving Patient Safety Culture in Primary Care: A Systematic Review.

    Science.gov (United States)

    Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2016-09-01

    Patient safety culture, described as shared values, attitudes and behavior of staff in a health-care organization, gained attention as a subject of study as it is believed to be related to the impact of patient safety improvements. However, in primary care, it is yet unknown, which effect interventions have on the safety culture. To review literature on the use of interventions that effect patient safety culture in primary care. Searches were performed in PubMed, EMBASE, CINAHL, and PsychINFO on March 4, 2013. Terms defining safety culture were combined with terms identifying intervention and terms indicating primary care. Inclusion followed if the intervention effected patient safety culture, and effect measures were reported. The search yielded 214 articles from which two were eligible for inclusion. Both studies were heterogeneous in their interventions and outcome; we present a qualitative summary. One study described the implementation of an electronic medical record system in general practices as part of patient safety improvements. The other study facilitated 2 workshops for general practices, one on risk management and another on significant event audit. Results showed signs of improvement, but the level of evidence was low because of the design and methodological problems. These studies in general practice provide a first understanding of improvement strategies and their effect in primary care. As the level of evidence was low, no clear preference can be determined. Further research is needed to help practices make an informed choice for an intervention.

  8. Depth of anaesthesia monitoring during procedural sedation and analgesia: A systematic review and meta-analysis.

    Science.gov (United States)

    Conway, Aaron; Sutherland, Joanna

    2016-11-01

    Processed electroencephalogram-based depth of anaesthesia monitoring devices provide an additional method to monitor level of consciousness during procedural sedation and analgesia. The objective of this systematic review was to determine whether using a depth of anaesthesia monitoring device improves the safety and efficacy of sedation. Systematic review and meta-analysis. Electronic databases (CENTRAL; Medline; CINAHL) were searched up to May 2015. Randomised controlled trials that compared use of a depth of anaesthesia monitoring device to a control group who received standard monitoring during procedural sedation and analgesia were included. Study selection, data extraction and risk of bias assessment (Cochrane risk of bias tool) were performed by two reviewers. Safety outcomes were hypoxaemia, hypotension and adverse events. Efficacy outcomes were amount of sedation used, duration of sedation recovery and rate of incomplete procedures. A total of 16 trials (2138 participants) were included. Evidence ratings were downgraded to either low or moderate quality due to study limitations and imprecision. Meta-analysis of 8 trials (766 participants) found no difference in hypoxaemia (RR 0.87; 95% CI=0.67-1.12). No statistically significant difference in hypotension was observed in meta-analysis of 8 trials (RR 0.96; 95% CI=0.54-1.7; 942 participants). Mean dose of propofol was 51mg lower for participants randomised to depth of anaesthesia monitoring (95% CI=-88.7 to -13.3mg) in meta-analysis of results from four trials conducted with 434 participants who underwent interventional endoscopy procedures with propofol infusions to maintain sedation. The difference in recovery time between depth of anaesthesia and standard monitoring groups was not clinically significant (standardised mean difference -0.41; 95% CI=-0.8 to -0.02; I2=86%; 8 trials; 809 participants). Depth of anaesthesia monitoring did impact sedation titration during interventional procedures with propofol

  9. Review Article: Socio-Economic Implications of Poor Safety Practices

    African Journals Online (AJOL)

    Review Article: Socio-Economic Implications of Poor Safety Practices. LC Okoro. Abstract. No abstract. Journal of Medical Laboratory Science Vol.12(2) 2003: 28 - 32. Full Text: EMAIL FULL TEXT EMAIL FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL TEXT · http://dx.doi.org/10.4314/jmls.v12i2.35284.

  10. Immunization Safety Review: Thimerosal - Containing Vaccines and Neurodevelopmental Disorders

    National Research Council Canada - National Science Library

    Stratton, Kathleen; Gable, Alicia; McCormick, Marie C

    2001-01-01

    ..., and Marie C.McCormick, Editors Immunization Safety Review Committee Board on Health Promotion and Disease Prevention INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. Copyrightoriginal retained, the be not from cannot book, paper original however, for version formatting, authoritative the typesetting-specific created from the as publ...

  11. Agricultural Media Coverage of Farm Safety: Review of the Literature.

    Science.gov (United States)

    Evans, Jim; Heiberger, Scott

    2016-01-01

    Agricultural media merit increased attention in addressing dynamic changes in safety aspects of one of the nation's most hazardous industries. Changes in farming, such as larger-scale, new "niche" enterprises and new technologies, bring new forms of risk to the safety of those who live and work on farms and ranches. At the same time, traditional agricultural media--commercial firms that publish farm periodicals and commercial radio/television stations and networks that provide farm programming--are changing dramatically. In the face of media convergence, these enterprises provide an increasing menu of agricultural information services delivered by print, radio, and television, plus a host of new electronic media. This review of literature addressed the role and importance of commercial agricultural media in the United States, the scope and pattern of their safety coverage, and the opportunities they represent. The review involved searches of 14 bibliographic databases, as well as reference lists of relevant studies and contacts with farm safety experts. Analysis of 122 documents suggested that limited focus has been directed to the role of commercial agricultural media in safety decisions on US farms. Findings revealed that they continue to serve an efficient, early-stage role in creating awareness and interest, providing information, forming attitudes, and stirring consideration of farm safety. Potentials are seen as expanding through the interactive features of social media and other new services offered by these media firms. Findings also identified research needs, 100 farm safety topics for reporting, and opportunities for strengthening safety coverage by commercial agricultural media.

  12. Surgical procedures performed in the neonatal intensive care unit on critically ill neonates: feasibility and safety.

    Science.gov (United States)

    Mallick, Mohammad Saquib; Jado, Abdul Monem; Al-Bassam, Abdul Rahman

    2008-01-01

    Transferring unstable, ill neonates to and from the operating room carries significant risks and can lead to morbidity. We report on our experience in performing certain procedures in critically ill neonates in the neonatal intensive care unit (NICU). We examined the feasibility and safety of such an approach. All surgical procedures performed in the the NICU between January 1999 and December 2005 were analyzed in terms of demographic data, diagnosis, preoperative stability of the patient, procedures performed, complications and outcome. Operations were performed at bedside in the NICU in critically ill, unstable neonates who needed emergency surgery, in neonates of very low birth weight (stomies, 7 repairs of congenital diaphragmatic hernias, 4 ligations of patent ductus arteriosus, and various others. Birthweights ranged between 850 g and 3500 g (mean, 2000 g). Gestational age ranged between 25 to 42 weeks (mean, 33 weeks). Age at surgery was between 1 to 30 days (mean, 10 days). Preoperatively, 19 patients (51.3%) were on inotropic support and all were intubated and mechanically ventilated. There was no mortality related to surgical procedures. Postoperatively, one patient developed wound infection and disruption. Performing major surgical procedures in the the NICU is both feasible and safe. It is useful in very low birth weight, critically ill neonates who have a definite risk attached to transfer to the operating room. No special area is needed in the the NICU to perform complication-free surgery, but designing an operating room within the the NICU would be ideal.

  13. Automated surveillance to detect post-procedure safety signals of approved medical devices

    Science.gov (United States)

    Resnic, Frederic S.; Gross, Thomas P.; Marinac-Dabic, Danica; Loyo-Berrios, Nilsa; Donnelly, Sharon; Normand, Sharon-Lise T.; Matheny, Michael E.

    2016-01-01

    Context Assuring the safety of medical devices challenges current surveillance approaches which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the post-market evaluation of medical device safety. Objective To determine whether automated safety surveillance of clinical registries using a computerized tool can provide early warnings regarding the safety of new cardiovascular devices. Design Prospective propensity matched cohort analysis of seven newly introduced cardiovascular devices, utilizing data from patients undergoing percutaneous coronary intervention (PCI) in Massachusetts between April 2003 and October 2007. Setting and Patients All adults undergoing PCI in Massachusetts licensed hospitals utilizing clinical data captured in the Massachusetts implementation of the National Cardiovascular Data Repository CathPCI Registry. Main Outcome Measure The presence of any safety alert, triggered if the cumulative observed risk for a given device exceeded the upper 95% confidence interval (CI) of comparator control device. Predefined sensitivity analyses assessed robustness of alerts when triggered. Results We evaluated 74,427 consecutive interventional coronary procedures. Three of 21 safety analyses triggered sustained alerts in two implantable devices. Patients receiving Taxus Express2® drug eluting stents (DES) experienced a 1.28 fold (2.87% versus 2.25%, absolute risk increase of 0.62%, CI: 0.25-0.99%) increased risk of post-procedural myocardial infarction and a 1.21 fold increase major adverse cardiac events relative to alternative DES (4.24% vs. 3.50%, absolute increase of 0.74%, CI: 0.29-1.19%). Patients receiving the Angio-Seal STS® vascular closure device (VCD) experienced a 1.51 fold increased risk (1.09% vs. 0.72%, absolute increased risk 0.37%, CI: 0.03-0.71%) increased risk of major vascular complications compared with alternative VCD. Sensitivity analyses confirmed

  14. Graft-Free Sinus Augmentation Procedure: a Literature Review

    Directory of Open Access Journals (Sweden)

    Ginnady Pinchasov

    2014-04-01

    Full Text Available Objectives: The restoration of edentulous posterior maxilla with dental implants is challenging due to a deficient posterior alveolar ridge. Over the last decade an advance in the graftless bone augmentation procedures had occurred where the space left beneath the Schneiderian membrane is filled with blood clot in order to produce bone formation. The aim of present article is to review the scientific literature with respect to bone formation in the sinus, after membrane elevation procedure, without using any bone substitutes. Material and Methods: A comprehensive review of the current literature was conducted according to the PRISMA guidelines by accessing the NCBI PubMed database. The articles were searched from 1993 to 2013. English language articles with minimum one year patient follow-up and radiological and/or histological diagnostics of newly formed bone were included. Articles were excluded, if usage of bone graft or bone substitutes and/or usage of osteotome has been made during sinus lift operation. Results: A total of 19 studies were included: 2 studies were related to the sinus membrane’s osteogenic potential, 3 to the histological evidence of bone formation in monkeys and humans, 12 to the radiologic evidence of bone gain, and 2 to the space-maintaining management. 100% of the reviewed articles presented with increased bone formation and high implant survival rates resulting from the graft-free technique. Conclusions: It is clearly shown in the review that the potential of the maxillary sinus to heal and to form new bone without bone grafts or substitutes is of high nature.

  15. Isotretinoin and Timing of Procedural Interventions: A Systematic Review With Consensus Recommendations.

    Science.gov (United States)

    Spring, Leah K; Krakowski, Andrew C; Alam, Murad; Bhatia, Ashish; Brauer, Jeremy; Cohen, Joel; Del Rosso, James Q; Diaz, Lucia; Dover, Jeffrey; Eichenfield, Lawrence F; Gurtner, Geoffrey C; Hanke, C William; Jahnke, Marla N; Kelly, Kristen M; Khetarpal, Shilpi; Kinney, Megan A; Levy, Moise L; Leyden, James; Longaker, Michael T; Munavalli, Girish S; Ozog, David M; Prather, Heidi; Shumaker, Peter R; Tanzi, Elizabeth; Torres, Abel; Velez, Mara Weinstein; Waldman, Abigail B; Yan, Albert C; Zaenglein, Andrea L

    2017-08-01

    The notion that systemic isotretinoin taken within 6 to 12 months of cutaneous surgery contributes to abnormal scarring or delayed wound healing is widely taught and practiced; however, it is based on 3 small case series from the mid-1980s. To evaluate the body of literature to provide evidence-based recommendations regarding the safety of procedural interventions performed either concurrently with, or immediately following the cessation of systemic isotretinoin therapy. A panel of national experts in pediatric dermatology, procedural/cosmetic dermatology, plastic surgery, scars, wound healing, acne, and isotretinoin was convened. A systematic PubMed review of English-language articles published from 1982 to 2017 was performed using the following search terms: isotretinoin, 13-cis-retinoic acid, Accutane, retinoids, acitretin, surgery, surgical, laser, ablative laser, nonablative laser, laser hair removal, chemical peel, dermabrasion, wound healing, safety, scarring, hypertrophic scar, and keloid. Evidence was graded, and expert consensus was obtained. Thirty-two relevant publications reported 1485 procedures. There was insufficient evidence to support delaying manual dermabrasion, superficial chemical peels, cutaneous surgery, laser hair removal, and fractional ablative and nonablative laser procedures for patients currently receiving or having recently completed isotretinoin therapy. Based on the available literature, mechanical dermabrasion and fully ablative laser are not recommended in the setting of systemic isotretinoin treatment. Physicians and patients may have an evidence-based discussion regarding the known risk of cutaneous surgical procedures in the setting of systemic isotretinoin therapy. For some patients and some conditions, an informed decision may lead to earlier and potentially more effective interventions.

  16. Trials of bevacizumab in breast cancer - a safety review

    DEFF Research Database (Denmark)

    Kümler, Iben; Nielsen, Dorte Lisbet

    2012-01-01

    enables the reader to overview current knowledge on the efficacy and safety of bevacizumab in breast cancer. Expert opinion: Insight into complex risk-benefit calculations for bevacizumab is missing. In unselected patients with HER2-negative metastatic breast cancer, the risk of serious side effects...... for continued gains in therapy efficacy. Areas covered: The authors review Phase III data concerning the safety of bevacizumab in breast cancer, summarize data on efficacy and discuss the risk:benefit ratio of the drug. The data for this review were obtained by searching in the PubMed database. This review...... of bevacizumab overshadows the benefit of the drug. However, increased response rates and progression-free survival in the majority of Phase III trials suggest that the drug is of benefit in a subgroup of patients. Although requiring close monitoring, most side effects are manageable. Reliable, validated...

  17. Patient involvement in the safety of care: an integrative review

    Directory of Open Access Journals (Sweden)

    Thaynara de Oliveira Silva

    2016-06-01

    Full Text Available The aim of this integrative review was to survey the strategies adopted by health institutions that involve patients in care as a barrier to prevent incidents. A search was conducted in MEDLINE, LILACS, CINAHL and PubMed databases using the descriptors ‘patient safety’, ‘iatrogenic’, ‘medical error’ and ‘involvement’. The review included studies in full text published between 2003 and March 2016 in English, Spanish or Portuguese. It was found that the effective communication and the development of patients’ autonomy are the most advocated strategies. The level of evidence of studies was limited to four and six. The assessment or description of institutional practices involving patients in their safety emerged as a gap in scientific knowledge. The impact of this review is to demonstrate the need for randomized studies to identify effective interventions, directing health institutions towards change in the organizational culture, focusing on safety and patient-centered care.

  18. Safety analysis and review system (SARS) assessment report

    Energy Technology Data Exchange (ETDEWEB)

    Browne, E.T.

    1981-03-01

    Under DOE Order 5481.1, Safety Analysis and Review System for DOE Operations, safety analyses are required for DOE projects in order to ensure that: (1) potential hazards are systematically identified; (2) potential impacts are analyzed; (3) reasonable measures have been taken to eliminate, control, or mitigate the hazards; and (4) there is documented management authorization of the DOE operation based on an objective assessment of the adequacy of the safety analysis. This report is intended to provide the DOE Office of Plans and Technology Assessment (OPTA) with an independent evaluation of the adequacy of the ongoing safety analysis effort. As part of this effort, a number of site visits and interviews were conducted, and FE SARS documents were reviewed. The latter included SARS Implementation Plans for a number of FE field offices, as well as safety analysis reports completed for certain FE operations. This report summarizes SARS related efforts at the DOE field offices visited and evaluates the extent to which they fulfill the requirements of DOE 5481.1.

  19. Pregnancy outcome after loop electrosurgical excision procedure: a systematic review.

    Science.gov (United States)

    Crane, Joan M G

    2003-11-01

    To examine the association of loop electrosurgical excision procedure (LEEP) and subsequent pregnancy outcomes. A computerized search of MEDLINE and PubMed was conducted using the keys words "pregnancy" and "loop electrosurgical excision procedure," "LEEP," "LETZ," "LLETZ," or "loop excision." References from identified publications were manually searched and cross referenced to identify additional relevant articles. Studies were included that compared women who had had LEEP to women who had not had the procedure and that reported on subsequent pregnancy outcomes. Studies were excluded if there was no control group, if the LEEP was performed during the pregnancy, or if only an abstract was available. Five of 36 articles identified met the criteria for systematic review. Women who had had LEEP were more likely to have preterm birth (odds ratio [OR] 1.81, 95% confidence interval [CI] 1.18, 2.76; P = .006) and low birth weight infants (precipitous labor, labor induction, or neonatal intensive care unit admission. A subgroup analysis including only studies matching for smoking status revealed that preterm birth was still more common in women who had had LEEP (OR 2.53, 95% CI 1.42, 4.49; P = .001), but birth weight under 2500 g was no longer significantly different. LEEP appears to be associated with subsequent preterm birth, even when smoking status is matched. Studies with adequate sample size are needed to further evaluate the relationship of LEEP and preterm birth, controlling for potential confounders, including depth of the tissue sample.

  20. Safety of liver biopsy as a day procedure in Abuth Zaria, Nigeria.

    Science.gov (United States)

    Samuel, David Olorunfemi; Oluleke, Ibinaiye Philip; Omotara, Samaila Modupeola

    2012-10-01

    Chronic liver disease (CLD) is an important condition, diagnosed mainly by liver biopsy and is a leading cause of death among the working class group. It is a major burden in sub-Saharan Africa where it leads to hepatocellular carcinoma with a high mortality. This study was a retrospective one undertaken to determine the safety of performing liver biopsy procedure between January 2000 to January 2009 in terms of the frequency of indications and side effects. A total of 279 entries were found out of which 270 (96.77%) had a definitive liver biopsy histology result. The main indication for liver biopsy was chronic viral hepatitis in 150 patients (53.76%) while the commonest complication was the post-procedure pain that was seen in 16 patients (5.7%). The average duration of hospital stay after biopsy was 6.08 ± 0.52 hours.

  1. Effect of electronic device use on pedestrian safety : a literature review.

    Science.gov (United States)

    2016-04-01

    This literature review on the effect of electronic device use on pedestrian safety is part of a research project sponsored by the Office of Behavioral Safety Research in the National Highway Traffic Safety Administration (NHTSA). An extensive literat...

  2. Updating Human Factors Engineering Guidelines for Conducting Safety Reviews of Nuclear Power Plants

    Energy Technology Data Exchange (ETDEWEB)

    O, J.M.; Higgins, J.; Stephen Fleger - NRC

    2011-09-19

    The U.S. Nuclear Regulatory Commission (NRC) reviews the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed to the periodic update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool. To this end, the NRC is updating its guidance to stay current with recent research on human performance, advances in HFE methods and tools, and new technology being employed in plant and control room design. This paper describes the role of HFE guidelines in the safety review process and the content of the key HFE guidelines used. Then we will present the methodology used to develop HFE guidance and update these documents, and describe the current status of the update program.

  3. ENHANCING FOOD SAFETY AND STABILITY THROUGH IRRADIATION: A REVIEW

    Directory of Open Access Journals (Sweden)

    Manzoor Ahmad Shah

    2014-04-01

    Full Text Available Food irradiation is one of the non thermal food processing methods. It is the process of exposing food materials to the controlled amounts of ionizing radiations such as gamma rays, X-rays and accelerated electrons, to improve microbiological safety and stability. Irradiation disrupts the biological processes that lead to decay of food quality. It is an effective tool to reduce food-borne pathogens, spoilage microorganisms and parasites; to extend shelf-life and for insect disinfection. The safety and consumption of irradiated foods have been extensively studied at national levels and in international cooperations and have concluded that foods irradiated under appropriate technologies are both safe and nutritionally adequate. Specific applications of food irradiation have been approved by national legislations of more than 55 countries worldwide. This review aims to discuss the applications of irradiation in food processing with the emphasis on food safety and stability.

  4. Patient Safety Learning Systems: A Systematic Review and Qualitative Synthesis.

    Science.gov (United States)

    2017-01-01

    A patient safety learning system (sometimes called a critical incident reporting system) refers to structured reporting, collation, and analysis of critical incidents. To inform a provincial working group's recommendations for an Ontario Patient Safety Event Learning System, a systematic review was undertaken to determine design features that would optimize its adoption into the health care system and would inform implementation strategies. The objective of this review was to address two research questions: (a) what are the barriers to and facilitators of successful adoption of a patient safety learning system reported by health professionals and (b) what design components maximize successful adoption and implementation? To answer the first question, we used a published systematic review. To answer the second question, we used scoping study methodology. Common barriers reported in the literature by health care professionals included fear of blame, legal penalties, the perception that incident reporting does not improve patient safety, lack of organizational support, inadequate feedback, lack of knowledge about incident reporting systems, and lack of understanding about what constitutes an error. Common facilitators included a non-accusatory environment, the perception that incident reporting improves safety, clarification of the route of reporting and of how the system uses reports, enhanced feedback, role models (such as managers) using and promoting reporting, legislated protection of those who report, ability to report anonymously, education and training opportunities, and clear guidelines on what to report. Components of a patient safety learning system that increased successful adoption and implementation were emphasis on a blame-free culture that encourages reporting and learning, clear guidelines on how and what to report, making sure the system is user-friendly, organizational development support for data analysis to generate meaningful learning outcomes

  5. Current global and Korean issues in radiation safety of nuclear medicine procedures.

    Science.gov (United States)

    Song, H C

    2016-06-01

    In recent years, the management of patient doses in medical imaging has evolved as concern about radiation exposure has increased. Efforts and techniques to reduce radiation doses are focussed not only on the basis of patient safety, but also on the fundamentals of justification and optimisation in cooperation with international organisations such as the International Commission on Radiological Protection, the International Atomic Energy Agency, and the World Health Organization. The Image Gently campaign in children and Image Wisely campaign in adults to lower radiation doses have been initiated in the USA. The European Association of Nuclear Medicine paediatric dosage card, North American consensus guidelines, and Nuclear Medicine Global Initiative have recommended the activities of radiopharmaceuticals that should be administered in children. Diagnostic reference levels (DRLs), developed predominantly in Europe, may be an important tool to manage patient doses. In Korea, overexposure to radiation, even from the use of medical imaging, has become a public issue, particularly since the accident at the Fukushima nuclear power plant. As a result, the Korean Nuclear Safety and Security Commission revised the technical standards for radiation safety management in medical fields. In parallel, DRLs for nuclear medicine procedures have been collected on a nationwide scale. Notice of total effective dose from positron emission tomography-computed tomography for cancer screening has been mandatory since mid-November 2014. © The International Society for Prosthetics and Orthotics.

  6. Approaches to advancing blood safety through haemovigilance: a review.

    Science.gov (United States)

    Mwangi, J W; Kimani, D; Oduor, M

    2009-12-01

    Blood transfusion is always associated with some level of risk. Haemovigilance is a risk monitoring system integral to the practice of transfusion medicine whose ultimate purpose is to improve the quality and safety of transfusion therapy. To examine the contribution of haemovigilance to blood safety, including the approaches that some countries have taken to institute haemovigilance, and explore routes through which countries without such systems can achieve them. The internet and journals on the topic of haemovigilance and development of haemovigilance systems in the English language. Reputable journals on the topic of haemovigilance were examined for abstracts and papers. Abstracts based on known credible and distinguished sources were selected. Information on haemovigilance and the processes of developing haemovigilance in various countries was reviewed. The information from selected papers and abstracts was used for writing this paper. Varying processes for haemovigilance have been adopted by different countries. The more advanced systems have national/regional coordinating mechanisms. Availability of haemovigilance data has given transfusion services a clear understanding of problems associated with transfusion that need to be solved so as to improve transfusion safety. Although countries in sub-Saharan Africa have made considerable progress in enhancing blood safety in the recent past, nationally coordinated haemovigilance systems are lacking. Focus on haemovigilance systems is considered the next frontier to be conquered in enhancing blood safety in the region.

  7. Motor assessment instruments and psychometric procedures: A systematic review

    Directory of Open Access Journals (Sweden)

    Pâmella de Medeiros

    2017-03-01

    Full Text Available It was our objective to identify the psychometric elements to an epistemological reflection through a systematic review of cross-cultural validation procedures of TGMD-2 batteries, MABC-2 and KTK. Searches were carried out by two evaluators independently without year and language restrictions in six databases: Web of Science, Science Direct, Lilacs, Scopus, Pubmed and The ScientificElectronic Library Online - SciELO. The key words used were: "MABC", "TGMD" and "KTK" all of them combined with the word "validity". There was a total of 734 articles, of which, after the exclusion criteria, remained only 11 studies. It was found that there are differences between the authors in relation to the psychometric factors taken into account in cross-cultural validation. So that there was a lack of unanimity of the validation criteria of all studies in this field.

  8. Unmanned Aerial Vehicle Mishap Taxonomy for Range Safety Reviews

    Science.gov (United States)

    2016-02-01

    failures. 2 Robert E. Ball . The Fundamentals of Aircraft Combat Survivability Analysis and Design...for Range Safety Reviews, RCC 326-16, February 2016 2-9  Encounter with lightning , lost aileron control Scenario: Failure of a vehicle’s ground...A vehicle operator attempted to find a route between thunderstorms. The vehicle was lost after a lightning strike and apparent encounter with icing

  9. The Safety of Orthokeratology?A Systematic Review

    OpenAIRE

    Liu, Yue M.; Xie, Peiying

    2015-01-01

    Objectives: The aim of this review is to evaluate the ocular safety of orthokeratology (OrthoK) treatment of myopia correction and retardation. Data Sources: Clinical studies published in English and Chinese were identified from MEDLINE, EMBASE CNKI, CQVIP, and WANFANG DATA (all from 1980 to April 2015). The reference lists of the studies and the Science Citation Index were also searched. Selection Criteria: Relevant clinical studies including case series, case reports, patient/practitioner s...

  10. Nursing care in the anesthetic procedure: an integrative review

    Directory of Open Access Journals (Sweden)

    Cassiane de Santana Lemos

    2016-02-01

    Full Text Available Abstract OBJECTIVE To search for the scientific evidence available on nursing professional actions during the anesthetic procedure. METHOD An integrative review of articles in Portuguese, English and Spanish, indexed in MEDLINE/PubMed, CINAHL, LILACS, National Cochrane, SciELO databases and the VHL portal. RESULTS Seven studies were analyzed, showing nurse anesthetists' work in countries such as the United States and parts of Europe, with the formulation of a plan for anesthesia and patient care regarding the verification of materials and intraoperative controls. The barriers to their performance involved working in conjunction with or supervised by anesthesiologists, the lack of government guidelines and policies for the legal exercise of the profession, and the conflict between nursing and the health system for maintenance of the performance in places with legislation and defined protocols for the specialty. Conclusion Despite the methodological weaknesses found, the studies indicated a wide diversity of nursing work. Furthermore, in countries absent of the specialty, like Brazil, the need to develop guidelines for care during the anesthetic procedure was observed.

  11. Home safety education and provision of safety equipment for injury prevention (Review).

    Science.gov (United States)

    Kendrick, Denise; Young, Ben; Mason-Jones, Amanda J; Ilyas, Nohaid; Achana, Felix A; Cooper, Nicola J; Hubbard, Stephanie J; Sutton, Alex J; Smith, Sherie; Wynn, Persephone; Mulvaney, Caroline; Watson, Michael C; Coupland, Carol

    2013-05-01

    In industrialised countries injuries (including burns, poisoning or drowning) are the leading cause of childhood death and steep social gradients exist in child injury mortality and morbidity. The majority of injuries in pre-school children occur at home but there is little meta-analytic evidence that child home safety interventions reduce injury rates or improve a range of safety practices, and little evidence on their effect by social group. We evaluated the effectiveness of home safety education, with or without the provision of low cost, discounted or free equipment (hereafter referred to as home safety interventions), in reducing child injury rates or increasing home safety practices and whether the effect varied by social group. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2009, Issue 2) in The Cochrane Library, MEDLINE (Ovid), EMBASE (Ovid), PsycINFO (Ovid), ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED), ISI Web of Science: Social Sciences Citation Index (SSCI), ISI Web of Science: Conference Proceedings Citation Index- Science (CPCI-S), CINAHL (EBSCO) and DARE (2009, Issue 2) in The Cochrane Library. We also searched websites and conference proceedings and searched the bibliographies of relevant studies and previously published reviews. We contacted authors of included studies as well as relevant organisations. The most recent search for trials was May 2009. Randomised controlled trials (RCTs), non-randomised controlled trials and controlled before and after (CBA) studies where home safety education with or without the provision of safety equipment was provided to those aged 19 years and under, and which reported injury, safety practices or possession of safety equipment. Two authors independently assessed study quality and extracted data. We attempted to obtain individual participant level data (IPD) for all included studies and summary data and IPD were simultaneously combined in meta-regressions by social

  12. A Review of General Aviation Safety (1984-2017).

    Science.gov (United States)

    Boyd, Douglas D

    2017-07-01

    General aviation includes all civilian aviation apart from operations involving paid passenger transport. Unfortunately, this category of aviation holds a lackluster safety record, accounting for 94% of civil aviation fatalities. In 2014, of 1143 general aviation accidents, 20% were fatal compared with 0 of 29 airline mishaps in the United States. Herein, research findings over the past 30 yr will be reviewed. Accident risk factors (e.g., adverse weather, geographical region, post-impact fire, gender differences) will be discussed. The review will also summarize the development and implementation of stringent crashworthiness designs with multi-axis dynamic testing and head-injury protection and its impact on mitigating occupant injury severity. The benefits and drawbacks of new technology and human factor considerations associated with increased general aviation automation will be debated. Data on the safety of the aging general aviation population and increased drug usage will also be described. Finally, areas in which general aviation occupant survival could be improved and injury severity mitigated will be discussed with the view of equipping aircraft with 1) crash-resistant fuel tanks to reduce post-impact conflagration; 2) after-market ballistic parachutes for older aircraft; and 3) current generation electronic locator beacons to hasten site access by first responders.Boyd DD. A review of general aviation safety (1984-2017). Aerosp Med Hum Perform. 2017; 88(7):657-664.

  13. Processes and Procedures for Application of CFD to Nuclear Reactor Safety Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Richard W. Johnson; Richard R. Schultz; Patrick J. Roache; Ismail B. Celik; William D. Pointer; Yassin A. Hassan

    2006-09-01

    Traditionally, nuclear reactor safety analysis has been performed using systems analysis codes such as RELAP5, which was developed at the INL. However, goals established by the Generation IV program, especially the desire to increase efficiency, has lead to an increase in operating temperatures for the reactors. This increase pushes reactor materials to operate towards their upper temperature limits relative to structural integrity. Because there will be some finite variation of the power density in the reactor core, there will be a potential for local hot spots to occur in the reactor vessel. Hence, it has become apparent that detailed analysis will be required to ensure that local ‘hot spots’ do not exceed safety limits. It is generally accepted that computational fluid dynamics (CFD) codes are intrinsically capable of simulating fluid dynamics and heat transport locally because they are based on ‘first principles.’ Indeed, CFD analysis has reached a fairly mature level of development, including the commercial level. However, CFD experts are aware that even though commercial codes are capable of simulating local fluid and thermal physics, great care must be taken in their application to avoid errors caused by such things as inappropriate grid meshing, low-order discretization schemes, lack of iterative convergence and inaccurate time-stepping. Just as important is the choice of a turbulence model for turbulent flow simulation. Turbulence models model the effects of turbulent transport of mass, momentum and energy, but are not necessarily applicable for wide ranges of flow types. Therefore, there is a well-recognized need to establish practices and procedures for the proper application of CFD to simulate flow physics accurately and establish the level of uncertainty of such computations. The present document represents contributions of CFD experts on what the basic practices, procedures and guidelines should be to aid CFD analysts to obtain accurate

  14. Patient safety education for undergraduate medical students: a systematic review

    Directory of Open Access Journals (Sweden)

    Zhang Mingming

    2011-06-01

    Full Text Available Abstract Background To reduce harm caused by health care is a global priority. Medical students should be able to recognize unsafe conditions, systematically report errors and near misses, investigate and improve such systems with a thorough understanding of human fallibility, and disclose errors to patients. Incorporating the knowledge of how to do this into the medical student curriculum is an urgent necessity. This paper aims to systematically review the literature about patient safety education for undergraduate medical students in terms of its content, teaching strategies, faculty availability and resources provided so as to identify evidence on how to promote patient safety in the curriculum for medical schools. This paper includes a perspective from the faculty of a medical school, a major hospital and an Evidence Based Medicine Centre in Sichuan Province, China. Methods We searched MEDLINE, ERIC, Academic Source Premier(ASP, EMBASE and three Chinese Databases (Chinese Biomedical Literature Database, CBM; China National Knowledge Infrastructure, CNKI; Wangfang Data from 1980 to Dec. 2009. The pre-specified form of inclusion and exclusion criteria were developed for literature screening. The quality of included studies was assessed using Darcy Reed and Gemma Flores-Mateo criteria. Two reviewers selected the studies, undertook quality assessment, and data extraction independently. Differing opinions were resolved by consensus or with help from the third person. Results This was a descriptive study of a total of seven studies that met the selection criteria. There were no relevant Chinese studies to be included. Only one study included patient safety education in the medical curriculum and the remaining studies integrated patient safety into clinical rotations or medical clerkships. Seven studies were of a pre and post study design, of which there was only one controlled study. There was considerable variation in relation to contents

  15. 77 FR 26790 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2012-05-07

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Office... Safety Officer Medal of Valor Review Board (``Board'') to vote on the position of Board Chairperson... Safety Officer Medal of Valor Review Board carries out those advisory functions specified in 42 U.S.C...

  16. 75 FR 30859 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2010-06-02

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Office... meeting via conference call of the Public Safety Officer Medal of Valor Review Board to vote on the... . ] SUPPLEMENTARY INFORMATION: The Public Safety Officer Medal of Valor Review Board carries out those advisory...

  17. 76 FR 56226 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2011-09-12

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Office... meeting via conference call of the Public Safety Officer Medal of Valor Review Board to vote of the... Public Safety Officer Medal of Valor Review Board carries out those advisory functions specified in 42 U...

  18. 49 CFR 209.501 - Review of rail transportation safety and security route analysis.

    Science.gov (United States)

    2010-10-01

    ....820 § 209.501 Review of rail transportation safety and security route analysis. (a) Review of route... analysis does not support the railroad carrier's original selected route, that safety and security... 49 Transportation 4 2010-10-01 2010-10-01 false Review of rail transportation safety and security...

  19. Simulation of safety: a review of the state of the art in road safety simulation modelling.

    Science.gov (United States)

    Young, William; Sobhani, Amir; Lenné, Michael G; Sarvi, Majid

    2014-05-01

    Recent decades have seen considerable growth in computer capabilities, data collection technology and communication mediums. This growth has had considerable impact on our ability to replicate driver behaviour and understand the processes involved in failures in the traffic system. From time to time it is necessary to assess the level of development as a basis of determining how far we have come. This paper sets out to assess the state of the art in the use of computer models to simulate and assess the level of safety in existing and future traffic systems. It reviews developments in the area of road safety simulation models. In particular, it reviews computer models of driver and vehicle behaviour within a road context. It focuses on stochastic numerical models of traffic behaviour and how reliable these are in estimating levels of safety on the traffic network. Models of this type are commonly used in the assessment of traffic systems for capacity, delay and general performance. Adding safety to this assessment regime may allow more comprehensive assessment of future traffic systems. To date the models have focused primarily on vehicular traffic that is, cars and heavy vehicles. It has been shown that these models have potential in measuring the level of conflict on parts of the network and the measure of conflict correlated well with crash statistics. Interest in the prediction of crashes and crash severity is growing and new models are focusing on the continuum of general traffic conditions, conflict, severe conflict, crash and severe crashes. The paper also explores the general data types used to develop, calibrate and validate these models. Recent technological development in in-vehicle data collection, driver simulators and machine learning offers considerable potential for improving the behavioural base, rigour and application of road safety simulation models. The paper closes with some indication of areas of future development. Copyright © 2014. Published

  20. Safety and efficacy of rivaroxaban compared with warfarin in patients undergoing peripheral arterial procedures.

    Science.gov (United States)

    Talukdar, Anjan; Wang, S Keisin; Czosnowski, Lauren; Mokraoui, Nassim; Gupta, Alok; Fajardo, Andres; Dalsing, Michael; Motaganahalli, Raghu

    2017-10-01

    Rivaroxaban is a United States Food and Drug Administration-approved oral anticoagulant for venous thromboembolic disease; however, there is no information regarding the safety and its efficacy to support its use in patients after open or endovascular arterial interventions. We report the safety and efficacy of rivaroxaban vs warfarin in patients undergoing peripheral arterial interventions. This single-institution retrospective study analyzed all sequential patients from December 2012 to August 2014 (21 months) who were prescribed rivaroxaban or warfarin after a peripheral arterial procedure. Our study population was then compared using American College of Chest Physicians guidelines with patients then stratified as low, medium, or high risk for bleeding complications. Statistical analyses were performed using the Student t-test and χ 2 test to compare demographics, readmissions because of bleeding, and the need for secondary interventions. Logistic regression models were used for analysis of variables associated with bleeding complications and secondary interventions. The Fisher exact test was used for power analysis. There were 44 patients in the rivaroxaban group and 50 patients in the warfarin group. Differences between demographics and risk factors for bleeding between groups or reintervention rate were not statistically significant (P = .297). However, subgroup evaluation of the safety profile suggests that patients who were aged ≤65 years and on warfarin had an overall higher incidence of major bleeding (P = .020). Patients who were aged >65 years, undergoing open operation, had a significant risk for reintervention (P = .047) when they received rivaroxaban. Real-world experience using rivaroxaban and warfarin in patients after peripheral arterial procedures suggests a comparable safety and efficacy profile. Subgroup analysis of those requiring an open operation demonstrated a decreased bleeding risk when rivaroxaban was used (in those aged <65

  1. Current Status of Periodic Safety Review of HANARO Research Reactor

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Minjin; Ahn, Guk-Hoon; Lee, Choong Sung [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2016-10-15

    A PSR for a research reactor became a legal requirement as the Nuclear Safety Act was amended and came into effect in 2014. This paper describes the current status and methodology of the first Periodic Safety Review (PSR) of HANARO that is being performed. The legal requirements, work plan, and process of implementing a PSR are described. Because this is the first PSR for a research reactor, it is our understating that the operating organization and regulatory body should communicate well with each other to complete the PSR in a timely manner. The first PSR of HANARO is under way. In order to achieve a successful result, activities of the operation organization such as scheduling, maintaining consistency in input data for review, and reviewing the PSR reports that will require intensive resources should be well planned. This means the operating organization needs to incorporate appropriate measures to ensure the transfer of knowledge and expertise arising from the PSR via a contractor to the operation organization. It is desirable for the Regulatory Body to be involved in all stage of the PSR to prevent any waste of resources and minimize the potential for a reworking of the PSR and the need for an additional assessment and review as recommended by foreign experts.

  2. Procedures to relate the NII safety assessment principles for nuclear reactors to risk

    CERN Document Server

    Kelly, G N; Hemming, C R

    1985-01-01

    Within the framework of the Public Inquiry into the proposed pressurised water reactor (PWR) at Sizewell, estimates were made of the levels of individual and societal risk from a PWR designed in a manner which would conform to the safety assessment principles formulated by the Nuclear Installations Inspectorate (NII). The procedures used to derive these levels of risk are described in this report. The opportunity has also been taken to revise the risk estimates made at the time of the Inquiry by taking account of additional data which were not then available, and to provide further quantification of the likely range of uncertainty in the predictions. This re-analysis has led to small changes in the levels of risk previously evaluated, but these are not sufficient to affect the broad conclusions reached before. For a reactor just conforming to the NII safety assessment principles a maximum individual risk of fatal cancer of about 10 sup - sup 6 per year of reactor operation has been estimated; the societal ris...

  3. Documentation of Hanford Site independent review of the Hanford Waste Vitrification Plant Preliminary Safety Analysis Report. Revision 3

    Energy Technology Data Exchange (ETDEWEB)

    Herborn, D.I.

    1993-11-01

    Westinghouse Hanford Company (WHC) is the Integrating Contractor for the Hanford Waste Vitrification Plant (HWVP) Project, and as such is responsible for preparation of the HWVP Preliminary Safety Analysis Report (PSAR). The HWVP PSAR was prepared pursuant to the requirements for safety analyses contained in US Department of Energy (DOE) Orders 4700.1, Project Management System (DOE 1987); 5480.5, Safety of Nuclear Facilities (DOE 1986a); 5481.lB, Safety Analysis and Review System (DOE 1986b) which was superseded by DOE order 5480-23, Nuclear Safety Analysis Reports, for nuclear facilities effective April 30, 1992 (DOE 1992); and 6430.lA, General Design Criteria (DOE 1989). The WHC procedures that, in large part, implement these DOE requirements are contained in WHC-CM-4-46, Nonreactor Facility Safety Analysis Manual. This manual describes the overall WHC safety analysis process in terms of requirements for safety analyses, responsibilities of the various contributing organizations, and required reviews and approvals.

  4. Modern diaper performance: construction, materials, and safety review.

    Science.gov (United States)

    Dey, Swatee; Kenneally, Dianna; Odio, Mauricio; Hatzopoulos, Ioannis

    2016-07-01

    A review of the literature on diapers and diaper rash reveals that many clinicians are unfamiliar with modern diaper construction and materials as well as diaper safety testing methods. Typical modern diapers do not contain ingredients of concern such as latex and disperse dyes, but use ingredients such as spandex and pigments with a favorable safety profile. Today's disposable diaper is a high performance product whose carefully designed layers and liners provide optimal urine and feces absorption and an ever more clothing-like and comfortable fit. This is possible due to a variety of specialized polymer materials that provide optimal absorption of urine and feces, thereby minimizing skin exposure. © 2016 The International Society of Dermatology.

  5. Procedure for conducting probabilistic safety assessment: level 1 full power internal event analysis

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Won Dae; Lee, Y. H.; Hwang, M. J. [and others

    2003-07-01

    This report provides guidance on conducting a Level I PSA for internal events in NPPs, which is based on the method and procedure that was used in the PSA for the design of Korea Standard Nuclear Plants (KSNPs). Level I PSA is to delineate the accident sequences leading to core damage and to estimate their frequencies. It has been directly used for assessing and modifying the system safety and reliability as a key and base part of PSA. Also, Level I PSA provides insights into design weakness and into ways of preventing core damage, which in most cases is the precursor to accidents leading to major accidents. So Level I PSA has been used as the essential technical bases for risk-informed application in NPPs. The report consists six major procedural steps for Level I PSA; familiarization of plant, initiating event analysis, event tree analysis, system fault tree analysis, reliability data analysis, and accident sequence quantification. The report is intended to assist technical persons performing Level I PSA for NPPs. A particular aim is to promote a standardized framework, terminology and form of documentation for PSAs. On the other hand, this report would be useful for the managers or regulatory persons related to risk-informed regulation, and also for conducting PSA for other industries.

  6. 75 FR 54915 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2010-09-09

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Office... meeting/conference call of the Public Safety Officer Medal of Valor Review Board to vote on recommendations for the 2009-2010 Medal of Valor nominations, review issues relevant to the nomination review...

  7. Efficacy and Safety of Aspiration Sclerotherapy of Simple Hepatic Cysts: A Systematic Review

    NARCIS (Netherlands)

    Wijnands, T.F.M.; Gortjes, A.P.; Gevers, T.J.G.; Jenniskens, S.F.M.; Schultze Kool, L.J.; Potthoff, A.; Ronot, M.; Drenth, J.P.H.

    2016-01-01

    OBJECTIVE: Aspiration sclerotherapy is a percutaneous procedure indicated for treatment of symptomatic simple hepatic cysts. The efficacy and safety of this procedure have been sources of debate and disagreement for years. The purpose of this study was to assess the long-term efficacy and safety of

  8. A Systematic Review of Occupational Health and Safety Business Cases.

    Science.gov (United States)

    Lee, Geunjae

    2018-02-01

    Business cases are arguments developed to secure management commitment and approval for investment in an intervention. This systematic review evaluated 12 experimental and quasi-experimental studies on occupational health and safety interventions (OHSI) in various settings. The search engines used in this systematic review include PubMed, CINAHL, and Scopus. A cost and benefit analysis of OHSI was completed at the organizational level in these studies. The focus of this analysis included sample, design, theoretical framework, interventional strategies, and threats to validity and outcomes. Positive returns on investment of OHSI outcomes were shown in 10 of the studies. The other two studies concluded that their chosen OHSI were not cost-effective.

  9. The Impact of System Factors on Quality and Safety in Arterial Surgery: A Systematic Review.

    Science.gov (United States)

    Lear, R; Godfrey, A D; Riga, C; Norton, C; Vincent, C; Bicknell, C D

    2017-07-01

    A systems approach to patient safety proposes that a wide range of factors contribute to surgical outcome, yet the impact of team, work environment, and organisational factors, is not fully understood in arterial surgery. The aim of this systematic review is to summarize and discuss what is already known about the impact of system factors on quality and safety in arterial surgery. A systematic review of original research papers in English using MEDLINE, Embase, PsycINFO, and Cochrane databases, was performed according to PRISMA guidelines. Independent reviewers selected papers according to strict inclusion and exclusion criteria, and using predefined data fields, extracted relevant data on team, work environment, and organisational factors, and measures of quality and/or safety, in arterial procedures. Twelve papers met the selection criteria. Study endpoints were not consistent between papers, and most failed to report their clinical significance. A variety of tools were used to measure team skills in five papers; only one paper measured the relationship between team factors and patient outcomes. Two papers reported that equipment failures were common and had a significant impact on operating room efficiency. The influence of hospital characteristics on failure-to-rescue rates was tested in one large study, although their conclusions were limited to the American Medicare population. Five papers implemented changes in the patient pathway, but most studies failed to account for potential confounding variables. A small number of heterogenous studies have evaluated the relationship between system factors and quality or safety in arterial surgery. There is some evidence of an association between system factors and patient outcomes, but there is more work to be done to fully understand this relationship. Future research would benefit from consistency in definitions, the use of validated assessment tools, measurement of clinically relevant endpoints, and adherence to

  10. A review on safety and efficacy of products containing Longifolia

    Directory of Open Access Journals (Sweden)

    Abdul Hafeez Ahmad Hamdi

    2016-01-01

    Full Text Available Eurycoma longifolia (commonly called tongkat ali is a flowering plant in the family Simaroubaceae, native to Indonesia, Malaysia, and, to a lesser extent, Thailand, Vietnam and also Laos. The roots extract of E. longifolia, is a well-known traditional herbal medicine in Asia used for many purposes such as sexual dysfunction, aging, malaria, cancer, diabetes, anxiety, aches, constipation, exercise recovery, fever, increased energy, increased strength, leukemia, osteoporosis, stress, syphilis and glandular swelling. The roots are also used as an aphrodisiac, antibiotic, appetite stimulant and health supplement. It is very important to conserve this valuable medicinal plant for the health benefit of future generations. The purpose of this review article is to evaluate and summarize the existing literatures regarding the efficacy and safety of products which contain E. longifolia as its main ingredient. In summary, based on the literature evaluated in this review article, products which contain tongkat ali showed a clinical benefit on improving erectile dysfunction as well as a good safety profile. We recommend consumers to check the level of the bioactive compound “eurycomanone” as their guide before choosing any E. longifolia product.

  11. The efficacy and safety of the tension-free vaginal tape procedure do not depend on the method of analgesia.

    Science.gov (United States)

    Adamiak, Aneta; Milart, Paweł; Skorupski, Paweł; Kuchnicka, Katarzyna; Nestorowicz, Andrzej; Jakowicki, Jerzy; Rechberger, Tomasz

    2002-07-01

    The original tension-free vaginal tape (TVT) method, described by Ulmsten et al., routinely uses local anaesthesia during the procedure. Since the anaesthetic effect after local application of lidocaine hydrochloride was not always satisfactory we decided to introduce the spinal anaesthesia during this operation. The aim of the present study was to compare local and spinal anaesthesia with respect to their efficacy and safety in the TVT procedure. 103 women, with objectively confirmed stress urinary incontinence, were randomised into the study. Sixty-seven women were anaesthetised locally and 36 patients spinally. All TVT procedures were performed as originally described. Objective assessment of the influence of anaesthesia on intra-abdominal pressure at rest and during the cough test was done using a rectal catheter and a central venous pressure manometer. The efficacy of the TVT procedure was based on a gynaecological examination with a cough test and a three-degree subjective scale: complete cure, improvement or failure. The success of the TVT procedure performed under local anaesthesia is comparable with that achieved under spinal analgesia (p=0.42). The number of complications that occurred in the two groups does not differ significantly (p=0.57). Spinal anaesthesia impairs the ability to cough effectively during the TVT procedure. However, the efficacy and safety of the operations performed under this type of anaesthesia are comparable with the efficacy and safety of operations done under local anaesthesia.

  12. Procedural instruction in invasive bedside procedures: a systematic review and meta-analysis of effective teaching approaches.

    Science.gov (United States)

    Huang, Grace C; McSparron, Jakob I; Balk, Ethan M; Richards, Jeremy B; Smith, C Christopher; Whelan, Julia S; Newman, Lori R; Smetana, Gerald W

    2016-04-01

    Optimal approaches to teaching bedside procedures are unknown. To identify effective instructional approaches in procedural training. We searched PubMed, EMBASE, Web of Science and Cochrane Library through December 2014. We included research articles that addressed procedural training among physicians or physician trainees for 12 bedside procedures. Two independent reviewers screened 9312 citations and identified 344 articles for full-text review. Two independent reviewers extracted data from full-text articles. We included measurements as classified by translational science outcomes T1 (testing settings), T2 (patient care practices) and T3 (patient/public health outcomes). Due to incomplete reporting, we post hoc classified study outcomes as 'negative' or 'positive' based on statistical significance. We performed meta-analyses of outcomes on the subset of studies sharing similar outcomes. We found 161 eligible studies (44 randomised controlled trials (RCTs), 34 non-RCTs and 83 uncontrolled trials). Simulation was the most frequently published educational mode (78%). Our post hoc classification showed that studies involving simulation, competency-based approaches and RCTs had higher frequencies of T2/T3 outcomes. Meta-analyses showed that simulation (risk ratio (RR) 1.54 vs 0.55 for studies with vs without simulation, p=0.013) and competency-based approaches (RR 3.17 vs 0.89, peffective forms of training. This systematic review of bedside procedural skills demonstrates that the current literature is heterogeneous and of varying quality and rigour. Evidence is strongest for the use of simulation and competency-based paradigms in teaching procedures, and these approaches should be the mainstay of programmes that train physicians to perform procedures. Further research should clarify differences among instructional methods (eg, forms of hands-on training) rather than among educational modes (eg, lecture vs simulation). Published by the BMJ Publishing Group Limited

  13. DOE EERE Standard Operating Procedure Peer Review Best Practice and Procedures

    Energy Technology Data Exchange (ETDEWEB)

    None

    2009-01-18

    Objective review and advice from peers - peer review - provides managers, staff, and researchers with a powerful and effective tool for enhancing the management, relevance, effectiveness, and productivity of all of the EERE research, development

  14. Micro-invasive glaucoma surgery (MIGS): a review of surgical procedures using stents

    Science.gov (United States)

    Pillunat, Lutz E; Erb, Carl; Jünemann, Anselm GM; Kimmich, Friedemann

    2017-01-01

    Over the last decade several novel surgical treatment options and devices for glaucoma have been developed. All these developments aim to cause as little trauma as possible to the eye, to safely, effectively, and sustainably reduce intraocular pressure (IOP), to produce reproducible results, and to be easy to adopt. The term “micro-invasive glaucoma surgery (MIGS)” was used for summarizing all these procedures. Currently MIGS is gaining more and more interest and popularity. The possible reduction of the number of glaucoma medications, the ab interno approach without damaging the conjunctival tissue, and the probably safer procedures compared to incisional surgical methods may explain the increased interest in MIGS. The use of glaucoma drainage implants for lowering IOP in difficult-to-treat patients has been established for a long time, however, a variety of new glaucoma micro-stents are being manufactured by using various materials and are available to increase aqueous outflow via different pathways. This review summarizes published results of randomized clinical studies and extensive case report series on these devices, including Schlemm’s canal stents (iStent®, iStent® inject, Hydrus), suprachoroidal stents (CyPass®, iStent® Supra), and subconjunctival stents (XEN). The article summarizes the findings of published material on efficacy and safety for each of these approaches. PMID:28919702

  15. 10 CFR 35.610 - Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma...

    Science.gov (United States)

    2010-01-01

    ... units, teletherapy units, and gamma stereotactic radiosurgery units. 35.610 Section 35.610 Energy..., Teletherapy Units, and Gamma Stereotactic Radiosurgery Units § 35.610 Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. (a) A licensee...

  16. Wireless Ultrasound Guidance for Femoral Venous Cannulation in Electrophysiology: Impact on Safety, Efficacy, and Procedural Delay.

    Science.gov (United States)

    Rodríguez Muñoz, Daniel; Franco Díez, Eduardo; Moreno, Javier; Lumia, Giuseppe; Carbonell San Román, Alejandra; Segura De La Cal, Teresa; Matía Francés, Roberto; Hernández Madrid, Antonio; Zamorano Gómez, José Luis

    2015-09-01

    Ultrasound (US) guidance increases safety and efficacy in vascular cannulation and is considered the standard of care. However, barriers including workflow interference and the need to be assisted by a second operator limit its adoption in clinical routine. The use of wireless US (WUS) may overcome these barriers. The aim of this study was to assess the impact of a novel WUS probe during its initial implantation in an electrophysiology (EP) laboratory. Thirty-six patients requiring femoral venous cannulation for EP procedures were included in this single center, prospective, observational study, comparing WUS guidance with the anatomical landmark approach. The primary endpoint was time to successful cannulation. Secondary endpoints included rate of unsuccessful punctures, accidental arterial punctures, and workflow interference. Compared with anatomical landmark approach, WUS guidance significantly reduced mean time to successful cannulation (87.3 ± 94.3 vs 238.1 ± 294.7 seconds, P application of wireless technology in this setting contributed to overcoming some of the barriers preventing a more widespread clinical use of US guidance. © 2015 Wiley Periodicals, Inc.

  17. Safety of type and screen method compared to conventional antiglobulin crossmatch procedures for compatibility testing in Indian setting

    Directory of Open Access Journals (Sweden)

    Chaudhary Rajendra

    2011-01-01

    Full Text Available Background: Over the past 30 years, pretransfusion tests have undergone considerable modification. In 1984, AABB recommended that the full cross match could be replaced by an abbreviated cross match in patients with negative antibody screen. However, before implementation of such a policy, issue regarding safety of T & S needs to be evaluated. Objectives: The aim of pretransfusion testing (PTT is to ensure that enough red blood cells (RBCs in the selected red cell components will survive when transfused. Results and Conclusion: We have, therefore in this study; evaluated safety of T & S procedure for PTT in comparison with conventional test tube cross match. The T & S procedure gave a safety of 91.6%. Also, the usefulness of the T & S was shown through the detection of unexpected antibodies in 0.75% (15 out of 2026 of cases.

  18. 78 FR 25476 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2013-05-01

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Bureau... announcement of a meeting (via conference call-in) of the Public Safety Officer Medal of Valor Review Board to... Medal of Valor Review Board carries out those advisory functions specified in 42 U.S.C. 15202. Pursuant...

  19. 77 FR 51826 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2012-08-27

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Bureau.... SUMMARY: This is an announcement of a meeting of the Public Safety Officer Medal of Valor Review Board to review and vote on recommendations for the 2011-2012 Medal of Valor nominations, consider issues relevant...

  20. 78 FR 43227 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2013-07-19

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Office.... SUMMARY: This is an announcement of a meeting of the Public Safety Officer Medal of Valor Review Board to review and vote on recommendations for the 2012-2013 Medal of Valor nominations, consider issues relevant...

  1. Execution and evaluation of safety reviews in Schleswig-Holstein; Durchfuehrung und Bewertung von Sicherheitsueberpruefungen in Schleswig-Holstein

    Energy Technology Data Exchange (ETDEWEB)

    Glaser, H.; Scharlaug, F.H. [Ministerium fuer Soziales, Gesundheit, Familie, Jugend und Senioren des Landes Schleswig-Holstein, Kiel (Germany). Abt. VIII 6 - Reaktorsicherheit und Strahlenschutz

    2008-05-15

    The obligations contained in the operating permits of the Brokdorf (KBR) and Kruemmel (KKK) nuclear power stations, and Sec.19a of the Atomic Energy Act as amended on April 22, 2002, require safety reviews of the complete plants of KBR, KKK, and KKB Brunsbuettel to be conducted in time before a period of ten years has elapsed. The respective state of the art, operating experience, and advanced development of safety technology must be taken into account in this effort. Experience in conducting safety reviews has been available in Schleswig-Holstein since early 1989. In the interest of uniform evaluation of the safety reviews of the KRB, KKK, and KKB plants, the competent technical unit of the Schleswig-Holstein supervisory and licensing authority elaborated the main criteria for the scope of the analysis, the representation and evaluation of results in the light of the 'Guideline of Probabilistic Safety Analyses' adopted by the Safety Analyses of Nuclear Power Plants Working Party, and compiled it in an internal evaluation guideline. This serves to conduct a regular, transparent procedure limited in time and based on uniform, clear evaluation criteria. For level 1 and 2 PSA, for instance, the objective defined states that the core damage frequency must be on the order of 1E-05/a or lower, and the frequency of large early releases must be one order of magnitude (1E-06/a) less probable. The MSGF, with the assistance of expert consultants, seeks to perform the safety review and its final evaluation within two years after filing. If required, appropriate improvements must be proposed on the basis of this evaluation. In demonstrating that the goals of protection were complied with, the findings of the evaluation of plant operation as well as of deterministic and probabilistic analyses must be taken into account. The findings resulting from the review will be summarized by the MSGF in a report open to the public. (orig.)

  2. 42 CFR 8.28 - Expedited procedures for review of immediate suspension.

    Science.gov (United States)

    2010-10-01

    ... GENERAL PROVISIONS CERTIFICATION OF OPIOID TREATMENT PROGRAMS Procedures for Review of Suspension or Proposed Revocation of OTP Certification, and of Adverse Action Regarding Withdrawal of Approval of an Accreditation Body § 8.28 Expedited procedures for review of immediate suspension. (a) Applicability. When the...

  3. 40 CFR 63.54 - Preconstruction review procedures for new affected sources.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 9 2010-07-01 2010-07-01 false Preconstruction review procedures for new affected sources. 63.54 Section 63.54 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Act Sections, Sections 112(g) and 112(j) § 63.54 Preconstruction review procedures for new affected...

  4. Safety and efficacy of POEM for treatment of achalasia: a systematic review of the literature.

    Science.gov (United States)

    Crespin, Oscar M; Liu, Louis W C; Parmar, Ambica; Jackson, Timothy D; Hamid, Jemila; Shlomovitz, Eran; Okrainec, Allan

    2017-05-01

    Peroral endoscopic myotomy (POEM) is a novel intervention for the treatment of achalasia, which combines the advantages of endoscopic access and myotomy. The purpose of this study was to perform a systematic review of the literature to evaluate the efficacy and safety of POEM. The systematic review was conducted following the PRISMA guidelines. Evidence-Based Medicine Reviews, Cochrane Central Register of Controlled Trials, Ovid MEDLINE (R) including in-process and non-indexed citations were searched for POEM studies using the keywords: esophageal achalasia, POEM, endoscopy, natural orifice surgery, laparoscopic Heller myotomy (LHM), and related terms. Eckardt score, lower esophageal sphincter (LES) pressure, and reported complications were the main outcomes. Two authors reviewed the search result independently. A third reviewer resolved all disagreements. Data abstraction was pilot-tested and approved by all authors. Data were examined for clinical, methodological, and statistical heterogeneity with the aim of determining whether evidence synthesis using meta- analysis was possible. The search strategy retrieved 2894 citations. After removing duplicates and applying the exclusion criteria, 54 studies were selected for full-text review of which a total of 19 studies were considered eligible for further analysis. There were 10 retrospective and 9 prospective studies, including 1299 POEM procedures. No randomized control trial (RCT) was identified. Overall, the pre- and post-POEM Eckardt scores and LES pressure were significantly different. The most frequently reported complications were mucosal perforation, subcutaneous emphysema, pneumoperitoneum, pneumothorax, pneumomediastinum, pleural effusion, and pneumonia. The median follow-up was 13 months (range 3-24). POEM is a safe and effective alternative for the treatment of achalasia. However, only short-term follow-up data compared with LHM are available. RCTs and long-term follow-up studies are needed to establish

  5. 33 CFR 51.9 - Discharge review procedures.

    Science.gov (United States)

    2010-07-01

    ... writing to the Armed Forces Review/Correction Board Reading Room, Pentagon Concourse, Washington, DC 20310... of review. If the former member is deceased, written notice of DRB review will be sent to the... DRB may consider other probative evidence provided that all materials relied on by the DRB, except...

  6. The Safety of Orthokeratology--A Systematic Review.

    Science.gov (United States)

    Liu, Yue M; Xie, Peiying

    2016-01-01

    The aim of this review is to evaluate the ocular safety of orthokeratology (OrthoK) treatment of myopia correction and retardation. Clinical studies published in English and Chinese were identified from MEDLINE, EMBASE CNKI, CQVIP, and WANFANG DATA (all from 1980 to April 2015). The reference lists of the studies and the Science Citation Index were also searched. Relevant clinical studies including case series, case reports, patient/practitioner surveys, retrospective and prospective cohort studies, and clinical trials were all included in the review. The material of OrthoK lenses was limited to gas-permeable lens. This review incorporated a total of 170 publications, including 58 English and 112 Chinese literature. The risk of microbial keratitis in overnight OrthoK was similar to that of other overnight modality. The most common complication was corneal staining. Other clinically insignificant side effects included epithelial iron deposit, prominent fribrillary lines, and transient changes of corneal biomechanical properties. There was no long-term effect of OrthoK on corneal endothelium. There is sufficient evidence to suggest that OrthoK is a safe option for myopia correction and retardation. Long-term success of OrthoK treatment requires a combination of proper lens fitting, rigorous compliance to lens care regimen, good adherence to routine follow-ups, and timely treatment of complications.

  7. The Safety of Orthokeratology—A Systematic Review

    Science.gov (United States)

    Xie, Peiying

    2016-01-01

    Objectives: The aim of this review is to evaluate the ocular safety of orthokeratology (OrthoK) treatment of myopia correction and retardation. Data Sources: Clinical studies published in English and Chinese were identified from MEDLINE, EMBASE CNKI, CQVIP, and WANFANG DATA (all from 1980 to April 2015). The reference lists of the studies and the Science Citation Index were also searched. Selection Criteria: Relevant clinical studies including case series, case reports, patient/practitioner surveys, retrospective and prospective cohort studies, and clinical trials were all included in the review. The material of OrthoK lenses was limited to gas-permeable lens. Main Results: This review incorporated a total of 170 publications, including 58 English and 112 Chinese literature. The risk of microbial keratitis in overnight OrthoK was similar to that of other overnight modality. The most common complication was corneal staining. Other clinically insignificant side effects included epithelial iron deposit, prominent fribrillary lines, and transient changes of corneal biomechanical properties. There was no long-term effect of OrthoK on corneal endothelium. Conclusions: There is sufficient evidence to suggest that OrthoK is a safe option for myopia correction and retardation. Long-term success of OrthoK treatment requires a combination of proper lens fitting, rigorous compliance to lens care regimen, good adherence to routine follow-ups, and timely treatment of complications. PMID:26704136

  8. MANAGEMENT OF PATIENTS ON ANTICOAGULANT THERAPY UNDERGOING DENTAL SURGICAL PROCEDURES. Review Article.

    Directory of Open Access Journals (Sweden)

    Atanaska Dinkova

    2013-07-01

    Full Text Available Dental treatment performed in patients receiving oral anticoagulant drug therapy is becoming increasingly common in dental offices.The aim of oral anticoagulant therapy is to reduce blood coagulability to an optimal therapeutic range within which the patient is provided some degree of protection from thromboembolic events. This is achieved at the cost of a minor risk of haemorrhage. Frequently raised questions concern the safety and efficacy of the various anticoagulation regimens and their accompanying thromboembolic and bleeding risks relative to invasive dental procedures.The aim of this literature review is to evaluate the available evidence on the impact of anticoagulant medications on dental treatment and highlight certain patient management issues closely interrelated to various aspects of dental treatment. For that purpose literature search in the electronic database of Medscape, Pubmed-Medline, Science Direct, and EBSCO host, in the data base of Medical University Plovdiv and specialised published books in general medicine and dentistry was made.A total of 33 publications between 1995 and 2013 were identified: 12 review articles, 11 randomized controlled and non-randomised studies, 6 guidelines and practical guides, 1 meta-analysis and 3 specialised books.

  9. Development of seismic safety reevaluation procedure considering the ageing of NPP facilities

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Myoung Kue [Jeonju Univ., Cheonju (Korea, Republic of); Kim, J. M. [Cheonnam National Univ., Gwangju (Korea, Republic of); Kim, Y. S.; Cheong, S. H.; Kim, I. S.; Lee, M. G.; Kim, D. O. [Andong National Univ., Andong (Korea, Republic of); Lee, G. H. [Mokpo National Maritime Univ., Mokpo (Korea, Republic of)

    2003-03-15

    There are three of Nuclear Power Plants subject to the USI A-46 in Korea, including Kori No 1 and No 2 and Wolsung No 1. For the sake of resolution of the issue the possibility of adopting the GIP developed by the SQUG in USA is very high. In relation to the issue, this study addresses some technical improvements of the GIP including sloshing analysis based on multiple modes, seismic retrofit of cabinet for reduction of ICRS and modification of IRS depending on damping ratio. Dominant degradation factor and its affects NPP concrete elements are reviewed : chloride induced corrosion, carbonation of concrete elements, freezing and thawing of concrete elements, chemical and biological process, crack affect on concrete degradation. Various technical reports and papers about age-related degradation are reviewed for identification of degradation properties of NPP structures and components and degradation trend in NPP structures and components. This report summarizes numerical model for concrete degradation and development procedure of numerical models for concrete degradation. This report proposes the research necessity for performance evaluation of degraded concrete structure and selection of element for further study.

  10. Westinghouse independent safety review of Savannah River production reactors

    Energy Technology Data Exchange (ETDEWEB)

    Leggett, W.D.; McShane, W.J. (Westinghouse Hanford Co., Richland, WA (USA)); Liparulo, N.J.; McAdoo, J.D.; Strawbridge, L.E. (Westinghouse Electric Corp., Pittsburgh, PA (USA). Nuclear and Advanced Technology Div.); Toto, G. (Westinghouse Electric Corp., Pittsburgh, PA (USA). Nuclear Services Div.); Fauske, H.K. (Fauske and Associates, Inc., Burr Ridge, IL (USA)); Call, D.W. (Westinghouse Savannah R

    1989-04-01

    Westinghouse Electric Corporation has performed a safety assessment of the Savannah River production reactors (K,L, and P) as requested by the US Department of Energy. This assessment was performed between November 1, 1988, and April 1, 1989, under the transition contract for the Westinghouse Savannah River Company's preparations to succeed E.I. du Pont de Nemours Company as the US Department of Energy contractor for the Savannah River Project. The reviewers were drawn from several Westinghouse nuclear energy organizations, embody a combination of commercial and government reactor experience, and have backgrounds covering the range of technologies relevant to assessing nuclear safety. The report presents the rationale from which the overall judgment was drawn and the basis for the committee's opinion on the phased restart strategy proposed by E.I. du Pont de Nemours Company, Westinghouse, and the US Department of Energy-Savannah River. The committee concluded that it could recommend restart of one reactor at partial power upon completion of a list of recommended upgrades both to systems and their supporting analyses and after demonstration that the organization had assimilated the massive changes it will have undergone.

  11. Safety and tolerability review of lorcaserin in clinical trials.

    Science.gov (United States)

    Greenway, F L; Shanahan, W; Fain, R; Ma, T; Rubino, D

    2016-10-01

    Lorcaserin is a novel selective serotonin 2C receptor agonist indicated by the US Food and Drug Administration for chronic weight management in adults with obesity or overweight with ≥1 comorbidity. The safety and efficacy of lorcaserin were established during two Phase III clinical trials in patients without diabetes (BLOOM and BLOSSOM) and one Phase III clinical trial in patients with type 2 diabetes (BLOOM-DM). Headache was the most common adverse event experienced by patients during all Phase III trials. Additional adverse events occurring in >5% of patients receiving lorcaserin included dizziness, fatigue, nausea, dry mouth and constipation in patients without diabetes, and hypoglycaemia, back pain, cough and fatigue in patients with diabetes. In a pooled analysis of echocardiographic data collected during the three lorcaserin Phase III trials, the incidence of FDA-defined valvulopathy was similar in patients taking lorcaserin and the placebo. Here, the safety profile of lorcaserin at the FDA-approved dose of 10 mg twice daily is reviewed using data from the lorcaserin Phase III programme, with a focus on theoretical adverse events commonly associated with agonists of the serotonin receptor family. Based on the lorcaserin Phase III clinical trial data, lorcaserin is safe and well tolerated in the indicated patient populations. © 2016 World Obesity.

  12. Reviewing real-time performance of nuclear reactor safety systems

    Energy Technology Data Exchange (ETDEWEB)

    Preckshot, G.G. [Lawrence Livermore National Lab., CA (United States)

    1993-08-01

    The purpose of this paper is to recommend regulatory guidance for reviewers examining real-time performance of computer-based safety systems used in nuclear power plants. Three areas of guidance are covered in this report. The first area covers how to determine if, when, and what prototypes should be required of developers to make a convincing demonstration that specific problems have been solved or that performance goals have been met. The second area has recommendations for timing analyses that will prove that the real-time system will meet its safety-imposed deadlines. The third area has description of means for assessing expected or actual real-time performance before, during, and after development is completed. To ensure that the delivered real-time software product meets performance goals, the paper recommends certain types of code-execution and communications scheduling. Technical background is provided in the appendix on methods of timing analysis, scheduling real-time computations, prototyping, real-time software development approaches, modeling and measurement, and real-time operating systems.

  13. Safety of Moxibustion: A Systematic Review of Case Reports

    Directory of Open Access Journals (Sweden)

    Ji Xu

    2014-01-01

    Full Text Available Moxibustion is a traditional medical treatment originating in China. It involves using the heat of burning moxa to stimulate acupoints. It is considered safe and effective and is widely used throughout the world. The increasing use of moxibustion has drawn attention to the procedure’s adverse events (AEs. This review covers a total of 64 cases of AEs associated with moxibustion in 24 articles, reported in six countries. Some evidence of the risks of moxibustion has been found in these cases. AEs include allergies, burns, infection, coughing, nausea, vomiting, fetal distress, premature birth, basal cell carcinoma (BCC, ectropion, hyperpigmentation, and even death. The position, duration, distance between moxa and skin, proficiency of the practitioners, conditions of the patients, presence of smoke, and even the environment of treatment can affect the safety of moxibustion. Improving practitioner skill and regulating operations may reduce the incidence of adverse reactions and improve the security of moxibustion.

  14. Documentation of Hanford Site independent review of the Hanford Waste Vitrification Plant Preliminary Safety Analysis Report

    Energy Technology Data Exchange (ETDEWEB)

    Herborn, D.I.

    1991-10-01

    The requirements for Westinghouse Hanford independent review of the Preliminary Safety Analysis Report (PSAR) are contained in Section 1.0, Subsection 4.3 of WCH-CM-4-46. Specifically, this manual requires the following: (1) Formal functional reviews of the HWVP PSAR by the future operating organization (HWVP Operations), and the independent review organizations (HWVP and Environmental Safety Assurance, Environmental Assurance, and Quality Assurance); and (2) Review and approval of the HWVP PSAR by the Tank Waste Disposal (TWD) Subcouncil of the Safety and Environmental Advisory Council (SEAC), which provides independent advice to the Westinghouse Hanford President and executives on matters of safety and environmental protection. 7 refs.

  15. Current Sports: Medicine Issues. Annual Safety Education Review--1973.

    Science.gov (United States)

    Craig, Timothy T., Ed.

    This document is a collection of papers whose theme is sports safety. Section one, "Government Interest in Sports Safety," includes an article on Washington, D.C.'s focus on sports safety. Section two, "Medical Aspects of Safety in Sports," includes articles regarding the medical basis of restriction from athletics, orthopaedic restrictions, and…

  16. Safety of metamizole: a systematic review of the literature.

    Science.gov (United States)

    Andrade, S; Bartels, D B; Lange, R; Sandford, L; Gurwitz, J

    2016-10-01

    Metamizole was withdrawn from the market in the United States and several European countries following reports of fatal agranulocytosis among users, but is still available in many countries in Europe, South America and Asia. Over the past several decades, a number of epidemiologic studies have been conducted to quantify the risk of agranulocytosis and other adverse effects associated with metamizole and other non-narcotic analgesics. The objective of this study was to perform a systematic review of the safety of metamizole. Epidemiologic studies published between 1 January 1980 and 15 December 2014 were identified through systematic searches of PubMed and Google Scholar; the reference sections of selected articles were also reviewed to identify potentially relevant studies. Studies included in this review focused on the safety of metamizole, that is on outcomes such as haematologic abnormalities, gastrointestinal bleeding, anaphylaxis and hepatotoxicity. Two study investigators independently reviewed the abstracts and articles to determine relevant studies according to prespecified criteria. A total of 22 articles met the criteria for evaluation. The majority of studies that evaluated agranulocytosis indicated an increased risk associated with metamizole, with relative risk (RR) estimates ranging from 1·5 (95% CI, 0·8-2·7) to 40·2 (95% CI, 14·7-113·3). Findings of three case-control studies do not suggest an association between metamizole and aplastic anaemia. Of the five case-control studies that evaluated the risk of upper gastrointestinal bleeding, four found a statistically significant increased risk associated with metamizole (RR estimates ranging from 1·4 to 2·7). There is insufficient evidence to determine whether metamizole increases the risk of other outcomes (e.g. hepatic effects, anaphylaxis, congenital anomalies). Few studies evaluated the effects of dose, route of administration or duration of therapy. Published studies reported differences in

  17. A review of nonstandardized applicators digitization in Nucletron™ HDR procedures.

    Science.gov (United States)

    Wang, Kelin; Ferenci, Michele S; de la Zerda, Alberto; Padgett, Kyle R; Bossart, Elizabeth L; Chao, Ming; Shao, Hua; Zhang, Mutain

    2017-09-01

    The major errors in HDR procedures were failures to enter the correct treatment distance, which could be caused by either entering wrong transmission lengths or imprecisely digitizing the dwelling positions. Most of those errors were not easily avoidable by enhancing the HDR management level because they were caused by implementations of nonstandardized applicators utilizing transmission tubes of different lengths in standard HDR procedures. We performed this comprehensive study to include all possible situations with different nonstandardized applicators that frequently occurred in HDR procedures, provide corresponding situations with standard applicator as comparisons, list all possible errors and in planning, clarify the confusions in offsets setting, and provide mathematical and quantitative solutions for each given scenarios. Training on HDR procedures with nonstandardized applicators are normally not included in most residential program for medical physics, thus this study could be meaningful in both clinical and educational purpose. At precision of 1 mm, our study could be used as the essential and practical reference for finding the correct treatment length as well as locating the accurate dwelling positions in any HDR procedure with nonstandardized applicators. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

  18. Historical Patterns in the Types of Procedures Performed and Radiation Safety Practices Used in Nuclear Medicine From 1945-2009.

    Science.gov (United States)

    Van Dyke, Miriam E; Drozdovitch, Vladimir; Doody, Michele M; Lim, Hyeyeun; Bolus, Norman E; Simon, Steven L; Alexander, Bruce H; Kitahara, Cari M

    2016-07-01

    The authors evaluated historical patterns in the types of procedures performed in diagnostic and therapeutic nuclear medicine and the associated radiation safety practices used from 1945-2009 in a sample of U.S. radiologic technologists. In 2013-2014, 4,406 participants from the U.S. Radiologic Technologists (USRT) Study who previously reported working with medical radionuclides completed a detailed survey inquiring about the performance of 23 diagnostic and therapeutic radionuclide procedures and the use of radiation safety practices when performing radionuclide procedure-related tasks during five time periods: 1945-1964, 1965-1979, 1980-1989, 1990-1999, and 2000-2009. An overall increase in the proportion of technologists who performed specific diagnostic or therapeutic procedures was observed across the five time periods. Between 1945-1964 and 2000-2009, the median frequency of diagnostic procedures performed substantially increased (from 5 wk to 30 wk), attributable mainly to an increasing frequency of cardiac and non-brain PET scans, while the median frequency of therapeutic procedures performed modestly decreased (from 4 mo to 3 mo). Also a notable increase was observed in the use of most radiation safety practices from 1945-1964 to 2000-2009 (e.g., use of lead-shielded vials during diagnostic radiopharmaceutical preparation increased from 56 to 96%), although lead apron use dramatically decreased (e.g., during diagnostic imaging procedures, from 81 to 7%). These data describe historical practices in nuclear medicine and can be used to support studies of health risks for nuclear medicine technologists.

  19. Historical patterns in the types of procedures performed and radiation safety practices used in nuclear medicine from 1945–2009

    Science.gov (United States)

    Van Dyke, Miriam E.; Drozdovitch, Vladimir; Doody, Michele M.; Lim, Hyeyeun; Bolus, Norman E.; Simon, Steven L.; Alexander, Bruce H.; Kitahara, Cari M.

    2016-01-01

    We evaluated historical patterns in the types of procedures performed in diagnostic and therapeutic nuclear medicine and the associated radiation safety practices used from 1945–2009 in a sample of U.S. radiologic technologists. In 2013–2014, 4,406 participants from the U.S. Radiologic Technologists (USRT) Study who previously reported working with medical radionuclides completed a detailed survey inquiring about the performance of 23 diagnostic and therapeutic radionuclide procedures and the use of radiation safety practices when performing radionuclide procedure-related tasks during five time periods: 1945–1964, 1965–1979, 1980–1989, 1990–1999, and 2000–2009. We observed an overall increase in the proportion of technologists who performed specific diagnostic or therapeutic procedures across the five time periods. Between 1945–1964 and 2000–2009, the median frequency of diagnostic procedures performed substantially increased (5 per week to 30 per week), attributable mainly to an increasing frequency of cardiac and non-brain PET scans, while the median frequency of therapeutic procedures performed modestly decreased (from 4 per month to 3 per month). We also observed a notable increase in the use of most radiation safety practices from 1945–1964 to 2000–2009 (e.g., use of lead-shielded vials during diagnostic radiopharmaceutical preparation increased from 56 to 96%), although lead apron use dramatically decreased (e.g., during diagnostic imaging procedures, from 81 to 7%). These data describe historical practices in nuclear medicine and can be used to support studies of health risks in nuclear medicine technologists. PMID:27218293

  20. Hypnosis for Acute Procedural Pain: A Critical Review.

    Science.gov (United States)

    Kendrick, Cassie; Sliwinski, Jim; Yu, Yimin; Johnson, Aimee; Fisher, William; Kekecs, Zoltán; Elkins, Gary

    2016-01-01

    Clinical evidence for the effectiveness of hypnosis in the treatment of acute procedural pain was critically evaluated based on reports from randomized controlled clinical trials (RCTs). Results from the 29 RCTs meeting inclusion criteria suggest that hypnosis decreases pain compared to standard care and attention control groups and that it is at least as effective as comparable adjunct psychological or behavioral therapies. In addition, applying hypnosis in multiple sessions prior to the day of the procedure produced the highest percentage of significant results. Hypnosis was most effective in minor surgical procedures. However, interpretations are limited by considerable risk of bias. Further studies using minimally effective control conditions and systematic control of intervention dose and timing are required to strengthen conclusions.

  1. Procedures for the ethical review of public health surveillance protocols

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2014-03-01

    Full Text Available The present commentary is based on the following considerations: 1 for the purposes of authorisation, a distinction is drawn between "research" and "intervention". The procedures for authorising the former are more complex, the relevant controls are stricter and approval has to be granted by a Research Ethics Committee (REC; 2 although the debate is still open, it is barely credible to claim that public health surveillance is not a form of research. It should, therefore, be subject to rigorous ethical assessment; 3 when addressing specifically the issue of surveillance, it would be appropriate to shift the focus of attention from the type of procedure (research/intervention to the risk implied in that procedure; 4 much emphasis has hitherto been placed on the risks that public health surveillance may imply for the protection of personal data; 5 the emphasis on the protection of personal data is frequently excessive and the risks should be examined in a broader context.

  2. Safety of bone marrow stem cell donation: a review.

    Science.gov (United States)

    Bosi, A; Bartolozzi, B

    2010-01-01

    Allogeneic hematopoietic stem cell transplantation (HSCT) represents the first choice of treatment or an important therapeutic option for several diseases, but it is still marked by morbidity and mortality. In contrast, the donation of hematopoietic stem cells (HSCs) is considered to be a safe procedure. The invaluable ethical source of donation and its central role in transplantation implies that the greatest attention be due to the donor and to the donation process through a serious monitoring protocol for donor safety. Both the Joint Accreditation Committee and the European Committee pay particular attention to the notification of adverse events and adverse reactions. Bone marrow donation is a well established procedure, that has now been performed for >30 years. Although it does not require drug administration, there is hospital admission for 1-3 days with 7-10 days off work. The main risk is related to the anesthesia. Pain in the aspiration area, together with astenia are considered to be the most frequent side effects, as shown by the USA National Marrow Donor Program experience in 1,193 donations. In the European Group for Blood and Marrow Transplantation analysis performed between 1993 and 2005 on 27,770 first HSCTs from bone marrow, only 1 fatal event (pulmonary embolism) and 12 serious adverse events were observed. The most frequent adverse events were cardiac. The incidence of adverse events was significantly lower (P donors, which confirms the necessity of accurate attention to donor selection and evaluation in bone marrow donation. Copyright 2010 Elsevier Inc. All rights reserved.

  3. 21 CFR Appendix A to Part 101 - Monier-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Monier-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition, Food and Drug Administration (November 1985...-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition...

  4. 21 CFR 56.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

    Science.gov (United States)

    2010-04-01

    ... categories of research that may be reviewed by the IRB through an expedited review procedure. The list will... uses an expedited review procedure shall adopt a method for keeping all members advised of research... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Expedited review procedures for certain kinds of...

  5. 42 CFR 405.1834 - CMS reviewing official procedure.

    Science.gov (United States)

    2010-10-01

    ... failed to demonstrate good cause for extending the time in which to request a hearing (as described in... there is a claim of privilege or other protection from disclosure such as case preparation..., general statements of policy, and rules of agency organization, procedure, or practice established by CMS...

  6. 78 FR 18965 - Submission for OMB Review; Comment Request: Safety Standard for Cigarette Lighters

    Science.gov (United States)

    2013-03-28

    ... COMMISSION Submission for OMB Review; Comment Request: Safety Standard for Cigarette Lighters AGENCY... a collection of information associated with the Commission's safety standard for cigarette lighters... the Safety Standard for Cigarette Lighters, 16 CFR part 1210. One comment was received in response to...

  7. NAFTA Revised Procedures for Joint Review of Microbials and Semiochemicals

    Science.gov (United States)

    The Canadian Pest Management Regulatory Agency and EPA have established a process for the joint review of pest control products in which the new active ingredient is a microbial or an arthropod semiochemical (including pheromones).

  8. [The peer review procedure and its place in medicine].

    Science.gov (United States)

    Chop, Ines; Eberlein-Gonska, Maria

    2012-01-01

    Peer Review literally meaning "re-inspection by a peer" is a special form of external evaluation whose roots go back to Ancient Greece and which is widely employed in science to assess manuscripts submitted for publication. In the medical context the Peer Review process is defined as structured critical self-reflection through dialogue with colleagues. Its prime objective is to improve the quality of patient care by identifying potentials for improvement and by deriving an action plan. Amongst other things, this includes medical standards and guidelines, indications and their traceability, the monitoring of the treatment process as well as the interdisciplinary cooperation and teamwork between different professional groups. The Peer Review practice in Germany has received strong impetus from comprehensive hospital operator projects like IQM, the "Initiative Qualitätsmedizin", and the Peer Review practice in intensive care. This practice, which has primarily been developed by practitioners for practitioners of their own accord, offers the chance to integrate medical quality with little bureaucratic effort and direct transfer of knowledge back into daily clinical work. Another important approach to promote peer reviewer qualifications is the curriculum "Medical Peer Review", which has been published by the German Medical Association since 2011. (As supplied by publisher). Copyright © 2012. Published by Elsevier GmbH.

  9. Safety of doxycycline and minocycline: a systematic review.

    Science.gov (United States)

    Smith, Kelly; Leyden, James J

    2005-09-01

    The goal of this review was to summarize the available literature covering the safety profiles of oral doxycycline and minocycline. Scientific literature published between 1966 and August 2003 was searched using the MEDLINE, EMBASE, and Biosis databases (search terms: minocycline or doxycycline, each paired with adverse reaction, adverse event, and side effect, and doxycycline or minocycline with the limits English language, human, and clinical trials). Safety information was collected from case reports and clinical trials. Adverse event (AE) rates in the United States were calculated by comparing data from the MedWatch AE reporting program used by the US Food and Drug Administration (FDA) with the number of new prescriptions dispensed for each drug from January 1998 to August 2003. Between 1966 and 2003, a total of 130 and 333 AEs were published in case reports of doxycycline and minocycline, respectively. In 24 doxycycline clinical trials (n = 3833) and 11 minocycline trials (n = 788), the ranges in incidence of AEs were 0% to 61% and 11.7% to 83.3%, respectively. Gastrointestinal AEs were most common with doxycycline; central nervous system and gastrointestinal AEs were most common with minocycline. From January 1998 to August 2003, the FDA MedWatch data contained 628 events for doxycycline and 1099 events for minocycline reported in the United States. Approximately 47,630,000 doxycycline and 15,234,000 minocycline new prescriptions were dispensed in the United States during that period, yielding event rates of 13 per million for doxycycline and 72 per million for minocycline, based on FDA data. Between 1998 and 2003, doxycycline was prescribed 3 times as often as minocycline. The incidence of AEs with either drug is very low, but doxycycline had fewer reported AEs. Although more head-to-head clinical trials are needed for a direct comparison of AE frequency, these preliminary data from separate reports suggest the possibility that AEs may be less likely with

  10. Propofol versus midazolam for procedural sedation in the emergency department : A study on efficacy and safety

    NARCIS (Netherlands)

    Lameijer, Heleen; Sikkema, Ytje T.; Pol, Albert; Bosch, Maike G. E.; Beije, Femke; Feenstra, Rieneke; Bens, Bas W. J.; ter Avest, Ewoud

    Background: Procedural sedation for painful procedures in the emergency department (ED) can be accomplished with various pharmacological agents. The choice of the sedative used is highly dependent on procedure- and patient characteristics and on personal- or local preferences. Methods: We conducted

  11. The Veterinary Forensic Necropsy: A Review of Procedures and Protocols.

    Science.gov (United States)

    Brownlie, H W Brooks; Munro, R

    2016-09-01

    Investigation of animal-related crime, and therefore submission of forensic cases to veterinary pathology facilities, is increasing, yet many veterinary pathologists are unfamiliar and often uncomfortable with involvement in the forensic necropsy. This article discusses various aspects of the forensic necropsy without specific attention to any particular species group or crime. General advice is given on procedures, documentation, and recording of the examination, and the article indicates how these features may differ from those used in investigation of natural disease. It also discusses evidence management, including recordkeeping, identification of evidence, labeling of photographs, and use of standard operating procedures and protocols. Various written and visual methods for documentation of the forensic necropsy are covered, and adjunctive topics such as sample collection, assessment, and description of wounds and taphonomy are included. Cause, mechanism, and manner of death are defined, and guidance to the use of these terms is given. The aim of this article is to offer guidance on procedural aspects of the forensic necropsy that will help those developing their forensic services, contribute to standardization of the provision of forensic veterinary pathology, and build the confidence of the "uncomfortable" forensic veterinary pathologist. © The Author(s) 2016.

  12. 76 FR 37375 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2011-06-27

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Office...: This is an announcement of a meeting via conference call of the Public Safety Officer Medal of Valor... Medal of Valor Review Board carries out those advisory functions specified in 42 U.S.C. 15202. Pursuant...

  13. Vaginal and Laparoscopic hysterectomy as an outpatient procedure: A systematic review.

    Science.gov (United States)

    Dedden, Suzanne J; Geomini, Peggy M A J; Huirne, Judith A F; Bongers, Marlies Y

    2017-09-01

    Laparoscopic and vaginal hysterectomies are common gynaecological procedures. Same-day discharge is usual care in various gynaecological procedures like laparoscopic sterilisation and laparoscopic oophorectomies. In major procedures like vaginal or laparoscopic hysterectomy patients are usually admitted overnight. We systematically reviewed the literature to identify complications, risk factors for (re)admittance, financial consequences and patient satisfaction of same-day discharge after a vaginal or laparoscopic hysterectomy. We systematically searched PubMed, UptoDate, Embase, Cochrane and CINAHL database from inception until July 16th 2016. We selected randomized controlled trials, prospective and retrospective cohort studies assessing the safety and feasibility of same-day discharge after vaginal or laparoscopic hysterectomy. The outcome parameters that were assessed were admission rate, re-admission rate, minor and major complications, patient satisfaction and financial consequences. 27 articles were included in the systematic review. All studies provided data about the admission rate and therefore failure of same-day discharge. Eleven prospective studies were included which compromised a total of 2391 hysterectomies. The percentage of overnight admissions was median 9.3% [0-25%]. Eight retrospective studies, which screened their patients before undergoing an outpatient hysterectomy, showed in 1500 subjects a mean admission rate of 10% [4,4-64%]. Four retrospective studies, which considered a large total cohort of 142,799 hysterectomies had a mean admission rate of 59,7% [48-79%]. The overall re-admission rate was low, varying from 0.73-4.0%. Minor complications were reported in respectively 4,3% and 7,3% in prospective respectively retrospective trials. Major complications were described in 0.7%-3.6% of all cases. Generally high satisfaction rates were reported in the observational trials. Same-day discharge after laparoscopic and vaginal hysterectomy seems

  14. Profiling safety of intravitreal injections for retinoblastoma using an anti-reflux procedure and sterilisation of the needle track.

    Science.gov (United States)

    Munier, Francis L; Soliman, Sameh; Moulin, Alexandre P; Gaillard, Marie-Claire; Balmer, Aubin; Beck-Popovic, Maja

    2012-08-01

    The preservation of globe integrity has always been a major concern during the treatment of retinoblastoma for fear of extraocular or metastatic spread. Intravitreal chemotherapy has been attempted as a desperate salvage therapy only for eyes with refractory retinoblastoma. Published data on the safety and efficacy of this route are, however, limited. A modified technique of intravitreal injection in eyes with retinoblastoma is described. All children with retinoblastoma who received one or more intravitreal injections using this technique were retrospectively reviewed concerning ocular complications of the injection procedure as well as clinical or histopathological evidence of tumour spread. 30 eyes of 30 children with retinoblastoma received a total of 135 intravitreal injections, with a median follw-up duration of 13.5 months. No extraocular spread was seen on clinical follow-up in any patients and there was no tumour contamination of the retrieved entry sites histopathologically analysed among the five enucleated eyes. No significant ocular side effects were observed except transient localised vitreous haemorrhage (3/135). This technique is potentially safe and effective at a low cost and may play a promising role, especially in the treatment of recurrent and/or resistant vitreous disease in retinoblastoma, as an alternative to enucleation and/or external beam radiotherapy. However, this treatment should not replace the primary standard of care of retinoblastoma and should not be considered in group E eyes. Its application should be approved by an ophthalmological-oncological team and it should be performed by an experienced eye surgeon in a tertiary referral centre after careful selection of a tumour-free injection site.

  15. D16.3 Proposal of procedures for assessment of preventive and active safety functions

    NARCIS (Netherlands)

    Scholliers, J.; Heinig, K.; Blosseville, J.M.; Netto, M.; Anttila, V.; Leanderson, S.; Engström, J.; Aust, M.L.; Hendriks, F.M.; Ploeg, J.; Chen, J.

    2007-01-01

    PReVAL addresses the possible safety impacts of functions developed and demonstrated in the PReVENT integrated project. One of the major aims of the PReVAL project is the development of a harmonized framework for the assessment of preventive safety applications and advanced driver assistance

  16. 75 FR 34064 - Manufactured Home Construction and Safety Standards, Test Procedures for Roof Trusses

    Science.gov (United States)

    2010-06-16

    ... reduce the overload test period from 12 hours to 6 hours, and allow the test specimens to be of average... URBAN DEVELOPMENT 24 CFR Part 3280 RIN 2502-A172 Manufactured Home Construction and Safety Standards... Construction and Safety Standards by adopting proposals made by the Manufactured Home Consensus Committee (MHCC...

  17. Safety in transportation: a review of the concept, its context, safety preservation and improvement effectiveness

    Directory of Open Access Journals (Sweden)

    Maciej SZCZUKOWSKI

    2017-06-01

    Full Text Available The article presents definitions of and approaches to the concept of safety in order to confirm the subjective character of its determination, description, and interpretation. By presenting examples of security statistics and safety-related behaviours, its ambiguity and complexity are revealed. The author draws attention to the media’s attitude towards safety-related incidents. With reference to contemporary scientific knowledge about the methods of improving safety in transportation organizations, the author also suggests that safety improvement initiatives should focus more strongly on facilitating closer cooperation between leaders, superiors and subordinates with different levels of experience.

  18. Micro-invasive glaucoma surgery (MIGS: a review of surgical procedures using stents

    Directory of Open Access Journals (Sweden)

    Pillunat LE

    2017-08-01

    Full Text Available Lutz E Pillunat,1 Carl Erb,2 Anselm GM Jünemann,3 Friedemann Kimmich4 1Department of Ophthalmology, University Hospital Carl Gustav Carus, Dresden, 2Augenklinik am Wittenbergplatz, Berlin, Germany; 3Department of Ophthalmology University of Rostock, Rostock, Germany; 4eyecons, Karlsruhe, Germany Abstract: Over the last decade several novel surgical treatment options and devices for glaucoma have been developed. All these developments aim to cause as little trauma as possible to the eye, to safely, effectively, and sustainably reduce intraocular pressure (IOP, to produce reproducible results, and to be easy to adopt. The term “micro-invasive glaucoma surgery (MIGS” was used for summarizing all these procedures. Currently MIGS is gaining more and more interest and popularity. The possible reduction of the number of glaucoma medications, the ab interno approach without damaging the conjunctival tissue, and the probably safer procedures compared to incisional surgical methods may explain the increased interest in MIGS. The use of glaucoma drainage implants for lowering IOP in difficult-to-treat patients has been established for a long time, however, a variety of new glaucoma micro-stents are being manufactured by using various materials and are available to increase aqueous outflow via different pathways. This review summarizes published results of randomized clinical studies and extensive case report series on these devices, including Schlemm’s canal stents (iStent®, iStent® inject, Hydrus, suprachoroidal stents (CyPass®, iStent® Supra, and subconjunctival stents (XEN. The article summarizes the findings of published material on efficacy and safety for each of these approaches. Keywords: glaucoma, micro-invasive glaucoma surgery, MIGS, iStent, iStent inject, CyPass, Hydrus, XEN

  19. 16 CFR 1021.7 - Coordination of environmental review with CPSC procedures.

    Science.gov (United States)

    2010-01-01

    ... CPSC procedures. 1021.7 Section 1021.7 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL... decisionmaking process. (c) Draft EISs or findings of no significant impact together with environmental.... Pursuant to § 1506.10 of the NEPA regulations, no decision on a proposed action shall be made by the...

  20. 75 FR 58408 - Subcommittee on Procedures Review, Advisory Board on Radiation and Worker Health (ABRWH...

    Science.gov (United States)

    2010-09-24

    ... Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health... radiation doses may have endangered the health of members of this class. The Subcommittee on Procedures... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND...

  1. Optimal training design for procedural motor skills: a review and application to laparoscopic surgery

    NARCIS (Netherlands)

    Spruit, E.N.; Band, G.P.H.; Hamming, J.F.; Ridderinkhof, K.R.

    2014-01-01

    This literature review covers the choices to consider in training complex procedural, perceptual and motor skills. In particular, we focus on laparoscopic surgery. An overview is provided of important training factors modulating the acquisition, durability, transfer, and efficiency of trained

  2. 45 CFR 46.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

    Science.gov (United States)

    2010-10-01

    ... SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.110 Expedited review procedures... list of categories of research that may be reviewed by the IRB through an expedited review procedure... reviewers may not disapprove the research. A research activity may be disapproved only after review in...

  3. Review of health safety aspects of nanotechnologies in food production.

    Science.gov (United States)

    Bouwmeester, Hans; Dekkers, Susan; Noordam, Maryvon Y; Hagens, Werner I; Bulder, Astrid S; de Heer, Cees; ten Voorde, Sandra E C G; Wijnhoven, Susan W P; Marvin, Hans J P; Sips, Adriënne J A M

    2009-02-01

    Due to new, previously unknown, properties attributed to engineered nanoparticles many new products are introduced in the agro-food area. Nanotechnologies cover many aspects, such as disease treatment, food security, new materials for pathogen detection, packaging materials and delivery systems. As with most new and evolving technologies, potential benefits are emphasized, while little is known on safety of the application of nanotechnologies in the agro-food sector. This review gives an overview of scientific issues that need to be addressed with priority in order to improve the risk assessment for nanoparticles in food. The following research topics are considered to contribute pivotally to risk assessment of nanotechnologies and nanoparticles in food products. Set a definition for NPs to facilitate regulatory discussions, prioritization of research and exchange of study results. Develop analytical tools for the characterization of nanoparticles in complex biological matrices like food. Establish relevant dose metrics for nanoparticles used for both interpretation of scientific studies as well as regulatory frameworks. Search for deviant behavior (kinetics) and novel effects (toxicity) of nanoparticles and assess the validity of currently used test systems following oral exposure. Estimate the consumer exposure to nanoparticles.

  4. Factors influencing the microbial safety of fresh produce: a review.

    Science.gov (United States)

    Olaimat, Amin N; Holley, Richard A

    2012-10-01

    Increased consumption, larger scale production and more efficient distribution of fresh produce over the past two decades have contributed to an increase in the number of illness outbreaks caused by this commodity. Pathogen contamination of fresh produce may originate before or after harvest, but once contaminated produce is difficult to sanitize. The prospect that some pathogens invade the vascular system of plants and establish "sub-clinical" infection needs to be better understood to enable estimation of its influence upon risk of human illness. Conventional surface sanitation methods can reduce the microbial load, but cannot eliminate pathogens if present. Chlorine dioxide, electrolyzed water, UV light, cold atmospheric plasma, hydrogen peroxide, organic acids and acidified sodium chlorite show promise, but irradiation at 1 kGy in high oxygen atmospheres may prove to be the most effective means to assure elimination of both surface and internal contamination of produce by pathogens. Pathogens of greatest current concern are Salmonella (tomatoes, seed sprouts and spices) and Escherichia coli O157:H7 on leafy greens (spinach and lettuce). This review considers new information on illness outbreaks caused by produce, identifies factors which influence their frequency and size and examines intervention effectiveness. Research needed to increase our understanding of the factors influencing microbial safety of fresh produce is addressed. Copyright © 2012 Elsevier Ltd. All rights reserved.

  5. The Safety of Ingested Caffeine: A Comprehensive Review

    Science.gov (United States)

    Temple, Jennifer L.; Bernard, Christophe; Lipshultz, Steven E.; Czachor, Jason D.; Westphal, Joslyn A.; Mestre, Miriam A.

    2017-01-01

    Caffeine is the most widely consumed psychoactive drug in the world. Natural sources of caffeine include coffee, tea, and chocolate. Synthetic caffeine is also added to products to promote arousal, alertness, energy, and elevated mood. Over the past decade, the introduction of new caffeine-containing food products, as well as changes in consumption patterns of the more traditional sources of caffeine, has increased scrutiny by health authorities and regulatory bodies about the overall consumption of caffeine and its potential cumulative effects on behavior and physiology. Of particular concern is the rate of caffeine intake among populations potentially vulnerable to the negative effects of caffeine consumption: pregnant and lactating women, children and adolescents, young adults, and people with underlying heart or other health conditions, such as mental illness. Here, we review the research into the safety and safe doses of ingested caffeine in healthy and in vulnerable populations. We report that, for healthy adults, caffeine consumption is relatively safe, but that for some vulnerable populations, caffeine consumption could be harmful, including impairments in cardiovascular function, sleep, and substance use. We also identified several gaps in the literature on which we based recommendations for the future of caffeine research. PMID:28603504

  6. The Safety of Ingested Caffeine: A Comprehensive Review.

    Science.gov (United States)

    Temple, Jennifer L; Bernard, Christophe; Lipshultz, Steven E; Czachor, Jason D; Westphal, Joslyn A; Mestre, Miriam A

    2017-01-01

    Caffeine is the most widely consumed psychoactive drug in the world. Natural sources of caffeine include coffee, tea, and chocolate. Synthetic caffeine is also added to products to promote arousal, alertness, energy, and elevated mood. Over the past decade, the introduction of new caffeine-containing food products, as well as changes in consumption patterns of the more traditional sources of caffeine, has increased scrutiny by health authorities and regulatory bodies about the overall consumption of caffeine and its potential cumulative effects on behavior and physiology. Of particular concern is the rate of caffeine intake among populations potentially vulnerable to the negative effects of caffeine consumption: pregnant and lactating women, children and adolescents, young adults, and people with underlying heart or other health conditions, such as mental illness. Here, we review the research into the safety and safe doses of ingested caffeine in healthy and in vulnerable populations. We report that, for healthy adults, caffeine consumption is relatively safe, but that for some vulnerable populations, caffeine consumption could be harmful, including impairments in cardiovascular function, sleep, and substance use. We also identified several gaps in the literature on which we based recommendations for the future of caffeine research.

  7. Lithium safety and tolerability in mood disorders: a critical review

    Directory of Open Access Journals (Sweden)

    Ivan Aprahamian

    2014-04-01

    Full Text Available Background : Lithium is a first-line treatment for bipolar disorder in all phases, also indicated as add-on drug for unipolar depression and suicide prevention. This study encompasses a broad critical review on the safety and tolerability of lithium for mood disorders. Methods : A computerized search for English written human studies was made in MEDLINE, using the keywords “lithium” and “mood disorders”, starting from July 1993 through July 2013 (n = 416. This initial search aimed to select clinical trials, prospective data, and controlled design studies of lithium treatment for mood disorders reporting adverse effects (n = 36. The final selection yielded 91 studies. Results : The most common general side effects in patients on lithium treatment were thirst, frequent urination, dry mouth, weight gain, fatigue and cognitive complaints. Lithium users showed a high prevalence of hypothyroidism, hyperparathyroidism, and decrease in urinary concentration ability. Reduction of glomerular filtration rate in patients using lithium was also observed, but in a lesser extent. The evidence of teratogenicity associated with lithium use is not well established. Anti-inflammatory non-steroidal drugs, thiazide diuretics, angiotensin-converting enzyme inhibitors, and alprazolam may increase serum lithium and the consequent risk for intoxication. Discussion : Short-term lithium treatment is associated with mild side effects. Medium and long-term lithium treatment, however, might have effects on target organs which may be prevented by periodical monitoring. Overall, lithium is still a safe option for the treatment of mood disorders.

  8. The Safety of Ingested Caffeine: A Comprehensive Review

    Directory of Open Access Journals (Sweden)

    Jennifer L. Temple

    2017-05-01

    Full Text Available Caffeine is the most widely consumed psychoactive drug in the world. Natural sources of caffeine include coffee, tea, and chocolate. Synthetic caffeine is also added to products to promote arousal, alertness, energy, and elevated mood. Over the past decade, the introduction of new caffeine-containing food products, as well as changes in consumption patterns of the more traditional sources of caffeine, has increased scrutiny by health authorities and regulatory bodies about the overall consumption of caffeine and its potential cumulative effects on behavior and physiology. Of particular concern is the rate of caffeine intake among populations potentially vulnerable to the negative effects of caffeine consumption: pregnant and lactating women, children and adolescents, young adults, and people with underlying heart or other health conditions, such as mental illness. Here, we review the research into the safety and safe doses of ingested caffeine in healthy and in vulnerable populations. We report that, for healthy adults, caffeine consumption is relatively safe, but that for some vulnerable populations, caffeine consumption could be harmful, including impairments in cardiovascular function, sleep, and substance use. We also identified several gaps in the literature on which we based recommendations for the future of caffeine research.

  9. A review of the regenerative endodontic treatment procedure.

    Science.gov (United States)

    Lee, Bin-Na; Moon, Jong-Wook; Chang, Hoon-Sang; Hwang, In-Nam; Oh, Won-Mann; Hwang, Yun-Chan

    2015-08-01

    Traditionally, apexification has been used to treat immature permanent teeth that have lost pulp vitality. This technique promotes the formation of an apical barrier to close the open apex so that the filling materials can be confined to the root canal. Because tissue regeneration cannot be achieved with apexification, a new technique called regenerative endodontic treatment was presented recently to treat immature permanent teeth. Regenerative endodontic treatment is a treatment procedure designed to replace damaged pulp tissue with viable tissue which restores the normal function of the pulp-dentin structure. After regenerative endodontic treatment, continued root development and hard tissue deposition on the dentinal wall can occur under ideal circumstances. However, it is difficult to predict the result of regenerative endodontic treatment. Therefore, the purpose of this study was to summarize multiple factors effects on the result of regenerative endodontic treatment in order to achieve more predictable results. In this study, we investigated the features of regenerative endodontic treatment in comparison with those of other pulp treatment procedures and analyzed the factors that have an effect on regenerative endodontic treatment.

  10. A review of the regenerative endodontic treatment procedure

    Directory of Open Access Journals (Sweden)

    Bin-Na Lee,

    2015-08-01

    Full Text Available Traditionally, apexification has been used to treat immature permanent teeth that have lost pulp vitality. This technique promotes the formation of an apical barrier to close the open apex so that the filling materials can be confined to the root canal. Because tissue regeneration cannot be achieved with apexification, a new technique called regenerative endodontic treatment was presented recently to treat immature permanent teeth. Regenerative endodontic treatment is a treatment procedure designed to replace damaged pulp tissue with viable tissue which restores the normal function of the pulp-dentin structure. After regenerative endodontic treatment, continued root development and hard tissue deposition on the dentinal wall can occur under ideal circumstances. However, it is difficult to predict the result of regenerative endodontic treatment. Therefore, the purpose of this study was to summarize multiple factors effects on the result of regenerative endodontic treatment in order to achieve more predictable results. In this study, we investigated the features of regenerative endodontic treatment in comparison with those of other pulp treatment procedures and analyzed the factors that have an effect on regenerative endodontic treatment.

  11. A review of current procedures for normalizing aircraft flyover noise data to reference meteorological conditions

    Science.gov (United States)

    Deloach, R.

    1977-01-01

    Procedures that are currently used to normalize raw aircraft noise data to reference weather conditions are reviewed. These procedures sometimes result in calculated values of molecular absorption which differ from measured values, especially at higher frequencies. An explanation is offered for this discrepancy, and its effect on normalized sound levels and on calculations of effective perceived noise level is examined.

  12. Review of Policy Documents for Nuclear Safety and Regulation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Woong Sik; Choi, Kwang Sik; Choi, Young Sung; Kim, Hho Jung; Kim, Ho Ki [Korea Institute of Nuclear Safety, Taejon (Korea, Republic of)

    2006-07-01

    The goal of regulation is to protect public health and safety as well as environment from radiological hazards that may occur as a result of the use of atomic energy. In September 1994, the Korean government issued the Nuclear Safety Policy Statement (NSPS) to establish policy goals of maintaining and achieving high-level of nuclear safety and also help the public understand the national policy and a strong will of the government toward nuclear safety. It declares the importance of establishing safety culture in nuclear community and also specifies five nuclear regulatory principles (Independence, Openness, Clarity, Efficiency and Reliability) and provides the eleven regulatory policy directions. In 2001, the Nuclear Safety Charter was declared to make the highest goal of safety in driving nuclear business clearer; to encourage atomic energy- related institutions and workers to keep in mind the mission and responsibility for assuring safety; to guarantee public confidence in related organizations. The Ministry of Science and Technology (MOST) also issues Yearly Regulatory Policy Directions at the beginning of every year. Recently, the third Atomic Energy Promotion Plan (2007-2011) has been established. It becomes necessary for the relevant organizations to prepare the detailed plans on such areas as nuclear development, safety management, regulation, etc. This paper introduces a multi-level structure of nuclear safety and regulation policy documents in Korea and presents some improvements necessary for better application of the policies.

  13. Prolapse surgery with or without incontinence procedure: a systematic review and meta-analysis.

    Science.gov (United States)

    van der Ploeg, J M; van der Steen, A; Zwolsman, S; van der Vaart, C H; Roovers, Jpwr

    2017-09-22

    To reduce the risk of postoperative stress urinary incontinence (POSUI) prolapse repair might be combined with incontinence surgery. Compare efficacy and safety of prolapse surgery with and without incontinence surgery. Including our earlier review a systematic search in PubMed, EMBASE, the Cochrane Library and the Register of Current Controlled Trials was performed from 1995 to 2017. Randomised trials comparing prolapse surgery with a midurethral sling (MUS) or Burch colposuspension. Two reviewers selected eligible articles and extracted data. Stress urinary outcomes were pooled for preoperative SUI. Urgency incontinence and adverse events were pooled for incontinence procedure. Ten trials were included. Women with preoperative SUI symptoms or occult SUI had a lower risk to undergo subsequent incontinence surgery for POSUI after vaginal prolapse surgery with a MUS than after prolapse surgery only: 0 versus 40% [relative risk (RR) 0.0; 95% CI 0.0-0.2] and 1 versus 15% (RR 0.1; 95% CI 0.0-0.6), respectively. These differences were not significant in continent women not tested for occult SUI or without occult SUI. Serious adverse events were more frequent after vaginal prolapse repair with MUS (14 versus 8%; RR 1.7; 95% CI 1.1-2.7), but not after sacrocolpopexy with Burch colposuspension. Combination surgery did not increase the risk of overactive bladder symptoms, urgency incontinence and surgery for voiding dysfunction. Vaginal prolapse repair with MUS reduced the risk of postoperative SUI in women with preoperative SUI symptoms or occult SUI, but serious adverse events were more frequent. Less stress incontinence after vaginal prolapse repair with sling, but more adverse events. © 2017 Royal College of Obstetricians and Gynaecologists.

  14. Measures of patient safety in developing and emerging countries: a review of the literature.

    Science.gov (United States)

    Carpenter, K B; Duevel, M A; Lee, P W; Wu, A W; Bates, D W; Runciman, W B; Baker, G R; Larizgoitia, I; Weeks, W B

    2010-02-01

    The World Alliance for Patient Safety was formed to accelerate worldwide research progress towards measurably improving patient safety. Although rates of adverse events have been studied in industrialised countries, little is known about the rates of adverse events in developing and emerging countries. To review the literature on patient safety issues in developing and emerging countries, to identify patient safety measures presently used in these countries and to propose a method of measurably improving patient safety measurement in these countries. Using the Medline database for 1998 to 2007, we identified and reviewed 23 English-language articles that examined patient safety measurement in developing and emerging countries. Results Our review included 12 studies that prospectively measured patient safety and 11 studies that retrospectively measured safety. Two studies used measures of structure and the remaining used process measures, outcome measures or both. Whereas a few studies used surveys or direct observation, most studies used chart audits to measure patient safety. Most studies addressed safety at a single facility. Investigation of patient safety in developing and emerging countries has been infrequent and limited in scope. Establishing fundamental safe patient practices, integrating those processes into routine health services delivery and developing patients' expectations that such processes be present are necessary prerequisites to measuring and monitoring progress towards safe patient care in emerging and developing countries.

  15. Discolouration potential of endodontic procedures and materials: a review.

    Science.gov (United States)

    Ahmed, H M A; Abbott, P V

    2012-10-01

    Advances in endodontic materials and techniques are at the forefront of endodontic research. Despite continuous improvements, tooth discolouration, especially in anterior teeth, is considered an undesirable consequence following endodontic treatment as it creates a range of aesthetic problems. This article aims to discuss the intrinsic and internalized tooth discolouration caused by endodontic procedures, and to address the discolouration potential of materials used during root canal treatment, including root canal irrigants, intra-canal medicaments, endodontic and post-endodontic filling materials. In addition, the discolouration patterns caused by combined endodontic and nonendodontic aetiological factors are discussed. The recommended guidelines that should be followed by dental practitioners to prevent and manage tooth discolouration are also outlined. © 2012 International Endodontic Journal.

  16. 7 CFR 1c.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

    Science.gov (United States)

    2010-01-01

    ... review procedures for certain kinds of research involving no more than minimal risk, and for minor... an expedited review procedure shall adopt a method for keeping all members advised of research... 7 Agriculture 1 2010-01-01 2010-01-01 false Expedited review procedures for certain kinds of...

  17. 49 CFR 11.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

    Science.gov (United States)

    2010-10-01

    ... Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor... an expedited review procedure shall adopt a method for keeping all members advised of research... 49 Transportation 1 2010-10-01 2010-10-01 false Expedited review procedures for certain kinds of...

  18. Safety impacts of bicycle infrastructure: A critical review.

    Science.gov (United States)

    DiGioia, Jonathan; Watkins, Kari Edison; Xu, Yanzhi; Rodgers, Michael; Guensler, Randall

    2017-06-01

    This paper takes a critical look at the present state of bicycle infrastructure treatment safety research, highlighting data needs. Safety literature relating to 22 bicycle treatments is examined, including findings, study methodologies, and data sources used in the studies. Some preliminary conclusions related to research efficacy are drawn from the available data and findings in the research. While the current body of bicycle safety literature points toward some defensible conclusions regarding the safety and effectiveness of certain bicycle treatments, such as bike lanes and removal of on-street parking, the vast majority treatments are still in need of rigorous research. Fundamental questions arise regarding appropriate exposure measures, crash measures, and crash data sources. This research will aid transportation departments with regard to decisions about bicycle infrastructure and guide future research efforts toward understanding safety impacts of bicycle infrastructure. Copyright © 2017 Elsevier Ltd and National Safety Council. All rights reserved.

  19. Nuclear Safety: Technical progress review, January-March 1988

    Energy Technology Data Exchange (ETDEWEB)

    Silver, E G [ed.

    1988-01-01

    This journal covers significant developments in the field of nuclear safety. Its scope includes the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials, and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated.

  20. Meat safety consequences of implementing visual postmortem meat inspection procedures in Danish slaughter pigs

    DEFF Research Database (Denmark)

    Mousing, Jan; Kyrval, J.; Jensen, Tim Kåre

    1997-01-01

    The consequences of a change from a traditional meat inspection procedure, including manual handling, palpation and incision, to an entirely postmortem meat inspection procedure in Danish slaughter pigs were assessed by a comparative study of the two methods in 188,383 slaughter pigs. Out of 58...

  1. Safety of oral midazolam sedation use in paediatric dentistry: a review.

    Science.gov (United States)

    Papineni, Arathi; Lourenço-Matharu, Liege; Ashley, Paul F

    2014-01-01

    Little information is available as to the safety of midazolam when used as an oral sedative. To evaluate the side effects and other adverse outcomes following use of oral midazolam for behaviour management in paediatric dentistry. A review of published literature relating to the safety and side effects of oral midazolam for use in paediatric dental procedures was conducted. Both randomised controlled trials and non-randomised studies were assessed. Reported side effects were recorded and classified as either significant or minor. The percentage prevalence of significant or minor side effects per episode of treatment was calculated. Sixteen papers of randomised controlled trials met the inclusion criteria. None of the side effects recorded were considered as significant. Minor side effects were reported (n = 68, 14%), with nausea and vomiting being the most frequently recorded (n = 30, 6%). Eleven papers of non-randomised studies were included. No significant side effects were recorded. Minor side effects were recorded (n = 157, 8%), with paradoxical reaction being the most common at 3.8%. Significant side effects associated with oral midazolam usage for behaviour management in children and adolescents requiring dental treatment appear to be rare. Minor side effects are more common but determining precise figures is complicated by poor reporting. © 2012 John Wiley & Sons Ltd, BSPD and IAPD.

  2. Evaluation procedures in health: Perspective of nursing care in patient safety.

    Science.gov (United States)

    da Costa, Theo Duarte; Santos, Viviane Euzébia Pereira; Junior, Marcos Antônio Ferreira; Vitor, Alynne Fortes; de Oliveira Salvador, Pétala Tuani Candido; Alves, Kisna Yasmin Andrade

    2017-06-01

    The objective research is analyzing the nursing care in intensive care units from the perspective of patient safety based on health evaluation. This is an evaluation research, for the purpose of issuance of judgment or judgment on a given system, carried out in six intensive care units. Data collection occurred from April to July 2014, in locu, with a validated instrument containing 97 questions related to patient safety. These, 73 items targeted to analyze the element "process" in safety patient nursing care. The 73 items were grouped into three elements meaning of the patient safety: "Communication and Identification", "Health and Comfort" and "Drug and Nutritional Therapy". Data analyses were used from Kappa measurement, observations conducted by the evaluators and literature on the theme. The result of three elements significant showed the following: 23 items (31.5%) were considered adequate and 50 (68.4%), non-compliant with the required standards for reliable care. Of these, 29 (39.7%) were classified as partially adequate and 21 (28.7%) as inadequate, setting a worrying care in regards care of security with large probability precipitation of undesirable events. It is emphasized that the classification unsuitability of items prevailed. Patient safety is impaired due to unsafe actions in nursing care processes. Unsafe actions in care processes increase the risk to patient safety, as precipitation falls, errors in medication administration, communication difficulties and continuity of care. Thus, immediate interventions are imperative to implement a safety culture and to avoid negligence in relation to care. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. A review of mechanisms and modelling procedures for landslide tsunamis

    Science.gov (United States)

    Løvholt, Finn; Harbitz, Carl B.; Glimsdal, Sylfest

    2017-04-01

    Landslides, including volcano flank collapses or volcanically induced flows, constitute the second-most important cause of tsunamis after earthquakes. Compared to earthquakes, landslides are more diverse with respect to how they generation tsunamis. Here, we give an overview over the main tsunami generation mechanisms for landslide tsunamis. In the presentation, a mix of results using analytical models, numerical models, laboratory experiments, and case studies are used to illustrate the diversity, but also to point out some common characteristics. Different numerical modelling techniques for the landslide evolution, and the tsunami generation and propagation, as well as the effect of frequency dispersion, are also briefly discussed. Basic tsunami generation mechanisms for different types of landslides, including large submarine translational landslide, to impulsive submarine slumps, and violent subaerial landslides and volcano flank collapses, are reviewed. The importance of the landslide kinematics is given attention, including the interplay between landslide acceleration, landslide velocity to depth ratio (Froude number) and dimensions. Using numerical simulations, we demonstrate how landslide deformation and retrogressive failure development influence tsunamigenesis. Generation mechanisms for subaerial landslides, are reviewed by means of scaling relations from laboratory experiments and numerical modelling. Finally, it is demonstrated how the different degree of complexity in the landslide tsunamigenesis needs to be reflected by increased sophistication in numerical models.

  4. Safety training and safe operating procedures written for PBFA (Particle Beam Fusion Accelerator) II and applicable to other pulsed power facilities

    Energy Technology Data Exchange (ETDEWEB)

    Donovan, G.L.; Goldstein, S.A.

    1986-12-01

    To ensure that work in advancing pulsed power technology is performed with an acceptably low risk, pulsed power research facilities at Sandia National Laboratories must satisfy general safety guidelines established by the Department of Energy, policies and formats of the Environment, Safety, and Health (ES and H) Department, and detailed procedures formulated by the Pulsed Power Sciences Directorate. The approach to safety training and to writing safe operating procedures, and the procedures presented here are specific to the Particle Beam Fusion Accelerator II (PBFA II) Facility but are applicable as guidelines to other research and development facilities which have similar hazards.

  5. FMCSA safety program effectiveness measurement : compliance review effectiveness model results for carriers with compliance reviews in fiscal year 2009.

    Science.gov (United States)

    2014-04-01

    In FY 2009, Federal and State enforcement personnel conducted more than 15,000 compliance reviews (CRs) on individual motor carriers. It is intended that through education, heightened safety regulation awareness, and the enforcement effects of the CR...

  6. FMCSA safety program effectiveness measurement : compliance review effectiveness model results for carriers with compliance reviews in FY 2008

    Science.gov (United States)

    2012-09-30

    In FY 2008, Federal and State enforcement personnel conducted 14,906 compliance reviews (CRs) on individual motor carriers. It is intended that through education, heightened safety regulation awareness, and the enforcement effects of the CR, carriers...

  7. 78 FR 78963 - Subcommittee on Procedures Review, Advisory Board on Radiation and Worker Health (ABRWH...

    Science.gov (United States)

    2013-12-27

    ... subcommittee: Time and Date: 11:00 a.m.-5:00 p.m. Eastern Time, February 13, 2014. Place: Audio Conference Call... submit written comments in advance of the meeting, to the contact person below. Written comments received... Review is responsible for overseeing, tracking, and participating in the reviews of all procedures used...

  8. 78 FR 78965 - Subcommittee on Procedures Review, Advisory Board on Radiation and Worker Health (ABRWH...

    Science.gov (United States)

    2013-12-27

    ... subcommittee: Time and Date: 11:00 a.m.-5:00 p.m. Eastern Time, February 13, 2014. Place: Audio Conference Call... submit written comments in advance of the meeting, to the contact person below. Written comments received... Review is responsible for overseeing, tracking, and participating in the reviews of all procedures used...

  9. A critical review on toxicological safety of 2-alkylcyclobutanones

    Science.gov (United States)

    Song, Beom-Seok; Choi, Soo-Jeong; Jin, Young-Bae; Park, Jong-Heum; Kim, Jae-Kyung; Byun, Eui-Baek; Kim, Jae-Hun; Lee, Ju-Woon; Kim, Gang-Sung; Marchioni, Eric

    2014-10-01

    2-Alkylcyclobutanones (2-ACBs) are known as unique radiolytic products generated from the major fatty acids and triglycerides in food through only irradiation. Since 1990, studies on the toxicological safety of 2-ACBs have been conducted extensively with synthetic compounds. Mutagenicity tests of 2-ACBs on the microorganisms reviewed in this study clearly indicate that no evidence was observed, while several in vitro studies demonstrated the cytotoxicity of 2-ACBs through cell death. Moreover, the genotoxicity of 2-ACBs was suggested as DNA strand breaks were observed. However, these findings should be interpreted with caution because genotoxicity may result from cytotoxicity, which causes DNA damage or from cell membrane destruction and indirect oxidative DNA damage. Therefore, elucidation of the mechanism of genotoxic effects is needed. With regards to the suggestion of Raul et al. (2002) who showed the promoting effect of colon cancer by the administration of 2-ACBs, further studies are needed to correct some experimental design errors. Moreover, an in-vivo experiment that evaluated the metabolism of 2-ACBs has revealed that 2-dDCB was metabolized into cyclic alcohol and excreted through fecal discharge. In conclusion, it is considered that the ingestion of 2-ACBs through irradiated foods is unlikely to affect the human health. However, more specific studies are required to identify the fate of 2-ACBs in body and the LD50 values. The determination of chronic toxicity by long-term exposure to low concentrations of 2-ACBs has to be evaluated more clearly to determine if these compounds are safe to human.

  10. Building safety and human behaviour in fire: A literature review

    NARCIS (Netherlands)

    Kobes, M.; Helsloot, I.; de Vries, B.; Post, J.

    2010-01-01

    The most crucial aspect of a building's safety in the face of fire is the possibility of safe escape. An important precondition is that its fire safety facilities enable independent and adequate fire response performances by the building's occupants. In practice, it appears that the measures

  11. Review of numerical procedures for computational surface thermochemistry

    Science.gov (United States)

    Milos, Frank S.; Rasky, Daniel J.

    1994-01-01

    Models and equations for surface thermochemistry and near-surface thermophysics of aerodynamically heated thermal protection materials are reviewed, with particular emphasis on computational boundary conditions for surface mass and energy transfer. The surface energy and mass balances, coupled with an appropriate ablation or surface catalysis model, provide complete thermochemical boundary conditions for a true multidisciplinary solution of the fully coupled fluid-dynamics/solid mechanics problem. Practical approximate solutions can be obtained by using a detailed model with full thermophysics for either the solid or fluid phase and a semianalytic method for the other half of the problem. A significant increase in the state-of-the-art in aerothermal computational fluid dynamics is possible by uniting computational fluid dynamic (CFD) methodology with surface thermochemistry boundary conditions and the heat-balance-integral method.

  12. Neighborhood safety factors associated with older adults' health-related outcomes: A systematic literature review.

    Science.gov (United States)

    Won, Jaewoong; Lee, Chanam; Forjuoh, Samuel N; Ory, Marcia G

    2016-09-01

    Neighborhood safety is important for older adults' health and wellbeing, but there has not been a synthesis in the literature of what is currently known about this construct. This systematic literature review, following the PRISMA guidelines, focuses on identifying neighborhood safety factors associated with health-related outcomes and behaviors of older adults in the U.S. A search was conducted in 2014 via Academic Search Complete, CINAHL, Embase, MEDLINE, SportDis, and Transportation Databases. Based on our inclusion and exclusion criteria, we identified thirty-two articles for review. Sixteen studies examined health outcomes such as health status, mental health, physical function, morbidity/mortality, and obesity; the other sixteen studies focused on health behaviors, such as physical activity and walking. Four domains of neighborhood safety were identified: overall/general neighborhood safety; crime-related safety; traffic-related safety; and proxies for safety (e.g., vandalism, graffiti). Overall/general neighborhood safety appeared most relevant to mental health and physical function. Traffic-related safety was most pertinent to physical activity, while crime-related safety was more consistently associated with mental health and walking. While all safety variables were significantly associated with mental health, no significant associations were found for obesity. We also found that specific measures or constructs of safety were not applied consistently across the examined studies, making it difficult to compare the results. This review identified several important gaps in the existing studies dealing with neighborhood safety-health relationships among older adults. Further studies are needed that examine the different roles of multidimensional neighborhood safety in promoting the community health, not only in the U.S., but globally. Copyright © 2016 Elsevier Ltd. All rights reserved.

  13. SAFETY AND EFFECTIVENESS OF SINGLE ANASTOMOSIS DUODENAL SWITCH PROCEDURE: PRELIMINARY RESULT FROM A SINGLE INSTITUTION.

    Science.gov (United States)

    Nelson, Lars; Moon, Rena C; Teixeira, Andre F; Galvão, Manoel; Ramos, Almino; Jawad, Muhammad A

    Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) was introduced into bariatric surgery by Sanchez-Pernaute et al. as an advancement of the biliopancreatic diversion with duodenal switch. To evaluate the SADI-S procedure with regard to weight loss, comorbidity resolution, and complication rate in the super obese population. A retrospective chart review was performed on initial 72 patients who underwent laparoscopic or robot-assisted laparoscopic SADI-S between December 17th, 2013 and July 29th, 2015. A total of 48 female and 21 male patients were included with a mean age of 42.4±10.0 years (range, 22-67). The mean body mass index (BMI) at the time of procedure was 58.4±8.3 kg/m2 (range, 42.3-91.8). Mean length of hospital stay was 4.3±2.6 days (range, 3-24). Thirty-day readmission rate was 4.3% (n=3), due to tachycardia (n=1), deep venous thrombosis (n=1), and viral gastroenteritis (n=1). Thirty-day reoperation rate was 5.8% (n=4) for perforation of the small bowel (n=1), leakage (n=1), duodenal stump leakage (n=1), and diagnostic laparoscopy (n=1). Percentage of excess weight loss (%EWL) was 28.5±8.8 % (range, 13.3-45.0) at three months (n=28), 41.7±11.1 % (range, 19.6-69.6) at six months (n=50), and 61.6±12.0 % (range, 40.1-91.2) at 12 months (n=23) after the procedure. A total of 18 patients (26.1%) presented with type II diabetes mellitus at the time of surgery. Of these patients, 9 (50.0%) had their diabetes resolved, and six (33.3%) had it improved by 6-12 months after SADI-S. SADI-S is a feasible operation with a promising weight loss and diabetes resolution in the super-obese population. Anastomose única em bypass duodenoileal com gastrectomia vertical (SADI-S) foi introduzida na cirurgia bariátrica por Sanchez-Pernaute et al. como um avanço da derivação biliopancreática com switch duodenal. Avaliar o procedimento SADI-S no que diz respeito à perda de peso, resolução de comorbidades e taxa de complicações na popula

  14. Duodopa® treatment for advanced Parkinson's disease: a review of efficacy and safety.

    Science.gov (United States)

    Nyholm, Dag

    2012-09-01

    Enterally administered levodopa/carbidopa gel (Duodopa®) is used for the treatment of advanced Parkinson's disease (PD) in patients with motor fluctuations and dyskinesias. This review summarizes the current efficacy and safety data on this drug. Clinically important differences (CID) have been used to assess whether statistical improvements in symptoms translate into meaningful improvements for the patients. A PubMed search in February 2012 found 23 papers with efficacy data and 33 with safety data. Of 11 studies reporting Unified Parkinson's Disease Rating Scale (UPDRS) III scores, 10 found improvements that met the CID of 10.8 points. Of 7 studies reporting UPDRS IV scores, 5 found improvements meeting the CID of 2.3 points. Quality of life (QoL) was assessed in 6 studies using the 8- or 39-question version of the Parkinson's disease Questionnaire, and all reported improvements meeting the CID (10 points). Due to the nature of the data, it is not possible to give exact numbers for the frequency of adverse events. However, the findings seem to be in line with a previous report stating the majority of adverse events were related to the infusion system or surgical procedure rather than the drug. In conclusion, the large majority of studies have reported that Duodopa® is clinically effective in relieving the symptoms of advanced PD and improving QoL in comparison with conventional therapy. High-quality randomized trials with larger patient numbers will yield greater insights into the efficacy and safety of this treatment. Copyright © 2012 Elsevier Ltd. All rights reserved.

  15. Patient safety culture in care homes for older people: a scoping review.

    Science.gov (United States)

    Gartshore, Emily; Waring, Justin; Timmons, Stephen

    2017-11-21

    In recent years, there has been an increasing focus on the role of safety culture in preventing incidents such as medication errors and falls. However, research and developments in safety culture has predominantly taken place in hospital settings, with relatively less attention given to establishing a safety culture in care homes. Despite safety culture being accepted as an important quality indicator across all health and social care settings, the understanding of culture within social care settings remains far less developed than within hospitals. It is therefore important that the existing evidence base is gathered and reviewed in order to understand safety culture in care homes. A scoping review was undertaken to describe the availability of evidence related to care homes' patient safety culture, what these studies focused on, and identify any knowledge gaps within the existing literature. Included papers were each reviewed by two authors for eligibility and to draw out information relevant to the scoping review. Twenty-four empirical papers and one literature review were included within the scoping review. The collective evidence demonstrated that safety culture research is largely based in the USA, within Nursing Homes rather than Residential Home settings. Moreover, the scoping review revealed that empirical evidence has predominantly used quantitative measures, and therefore the deeper levels of culture have not been captured in the evidence base. Safety culture in care homes is a topic that has not been extensively researched. The review highlights a number of key gaps in the evidence base, which future research into safety culture in care home should attempt to address.

  16. Patient safety culture in care homes for older people: a scoping review

    Directory of Open Access Journals (Sweden)

    Emily Gartshore

    2017-11-01

    Full Text Available Abstract Background In recent years, there has been an increasing focus on the role of safety culture in preventing incidents such as medication errors and falls. However, research and developments in safety culture has predominantly taken place in hospital settings, with relatively less attention given to establishing a safety culture in care homes. Despite safety culture being accepted as an important quality indicator across all health and social care settings, the understanding of culture within social care settings remains far less developed than within hospitals. It is therefore important that the existing evidence base is gathered and reviewed in order to understand safety culture in care homes. Methods A scoping review was undertaken to describe the availability of evidence related to care homes’ patient safety culture, what these studies focused on, and identify any knowledge gaps within the existing literature. Included papers were each reviewed by two authors for eligibility and to draw out information relevant to the scoping review. Results Twenty-four empirical papers and one literature review were included within the scoping review. The collective evidence demonstrated that safety culture research is largely based in the USA, within Nursing Homes rather than Residential Home settings. Moreover, the scoping review revealed that empirical evidence has predominantly used quantitative measures, and therefore the deeper levels of culture have not been captured in the evidence base. Conclusions Safety culture in care homes is a topic that has not been extensively researched. The review highlights a number of key gaps in the evidence base, which future research into safety culture in care home should attempt to address.

  17. Negotiating the relevance of laboratory work: Safety, procedures and accuracy brought to the fore in science education

    Directory of Open Access Journals (Sweden)

    Mattias Lundin

    2014-04-01

    Full Text Available This text addresses the problem of the discrepancy between teachers’ and students’ positions in negotiations about the authenticity and legitimacy of school science activities. The study focuses on the apparent conflicts concerning legitimacy and authenticity when teachers and students bring attention to safety, authenticity and accuracy during issues laboratory activities. The analysed data are excerpts made from video observations in two science classes. Analysis was made using epistemological moves describing how teachers and students make their activities relevant. The result indicates that in the classroom conversation about laboratory practice, teachers sometimes draw the attention to safety, procedures and accuracy to legitimize the activity and how they try to control it. Negotiations concerning the legitimacy and authenticity of activities seem inevitable. Unless understandable agreements are reached, the negotiations jeopardize a successful understanding of the Nature of Science (NOS. Misunderstanding of the authenticity of activities contributes to a reduction of their legitimacy, and undermining teaching of context independent knowledge.

  18. NASA Expendable Launch Vehicle (ELV) Payload Safety Review Process

    Science.gov (United States)

    Starbus, Calvert S.; Donovan, Shawn; Dook, Mike; Palo, Tom

    2007-01-01

    Issues addressed by this program: (1) Complicated roles and responsibilities associated with multi-partner projects (2) Working relationships and communications between all organizations involved in the payload safety process (3) Consistent interpretation and implementation of safety requirements from one project to the rest (4) Consistent implementation of the Tailoring Process (5) Clearly defined NASA decision-making-authority (6) Bring Agency-wide perspective to each ElV payload project. Current process requires a Payload Safety Working Group (PSWG) for eac payload with representatives from all involved organizations.

  19. A Review on Internet of Things for Defense and Public Safety

    Directory of Open Access Journals (Sweden)

    Paula Fraga-Lamas

    2016-10-01

    Full Text Available The Internet of Things (IoT is undeniably transforming the way that organizations communicate and organize everyday businesses and industrial procedures. Its adoption has proven well suited for sectors that manage a large number of assets and coordinate complex and distributed processes. This survey analyzes the great potential for applying IoT technologies (i.e., data-driven applications or embedded automation and intelligent adaptive systems to revolutionize modern warfare and provide benefits similar to those in industry. It identifies scenarios where Defense and Public Safety (PS could leverage better commercial IoT capabilities to deliver greater survivability to the warfighter or first responders, while reducing costs and increasing operation efficiency and effectiveness. This article reviews the main tactical requirements and the architecture, examining gaps and shortcomings in existing IoT systems across the military field and mission-critical scenarios. The review characterizes the open challenges for a broad deployment and presents a research roadmap for enabling an affordable IoT for defense and PS.

  20. A Review on Internet of Things for Defense and Public Safety

    Science.gov (United States)

    Fraga-Lamas, Paula; Fernández-Caramés, Tiago M.; Suárez-Albela, Manuel; Castedo, Luis; González-López, Miguel

    2016-01-01

    The Internet of Things (IoT) is undeniably transforming the way that organizations communicate and organize everyday businesses and industrial procedures. Its adoption has proven well suited for sectors that manage a large number of assets and coordinate complex and distributed processes. This survey analyzes the great potential for applying IoT technologies (i.e., data-driven applications or embedded automation and intelligent adaptive systems) to revolutionize modern warfare and provide benefits similar to those in industry. It identifies scenarios where Defense and Public Safety (PS) could leverage better commercial IoT capabilities to deliver greater survivability to the warfighter or first responders, while reducing costs and increasing operation efficiency and effectiveness. This article reviews the main tactical requirements and the architecture, examining gaps and shortcomings in existing IoT systems across the military field and mission-critical scenarios. The review characterizes the open challenges for a broad deployment and presents a research roadmap for enabling an affordable IoT for defense and PS. PMID:27782052

  1. A Review on Internet of Things for Defense and Public Safety.

    Science.gov (United States)

    Fraga-Lamas, Paula; Fernández-Caramés, Tiago M; Suárez-Albela, Manuel; Castedo, Luis; González-López, Miguel

    2016-10-05

    The Internet of Things (IoT) is undeniably transforming the way that organizations communicate and organize everyday businesses and industrial procedures. Its adoption has proven well suited for sectors that manage a large number of assets and coordinate complex and distributed processes. This survey analyzes the great potential for applying IoT technologies (i.e., data-driven applications or embedded automation and intelligent adaptive systems) to revolutionize modern warfare and provide benefits similar to those in industry. It identifies scenarios where Defense and Public Safety (PS) could leverage better commercial IoT capabilities to deliver greater survivability to the warfighter or first responders, while reducing costs and increasing operation efficiency and effectiveness. This article reviews the main tactical requirements and the architecture, examining gaps and shortcomings in existing IoT systems across the military field and mission-critical scenarios. The review characterizes the open challenges for a broad deployment and presents a research roadmap for enabling an affordable IoT for defense and PS.

  2. 14 CFR Appendix B of Part 415 - Safety Review Document Outline

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Safety Review Document Outline B Appendix B of Part 415 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION....3.4Trajectory and Debris Dispersion Data 4.3.5Flight Hazard Areas and Safety Clear Zones 4.3...

  3. Efficacy and safety of pregabalin in generalised anxiety disorder : A critical review of the literature

    NARCIS (Netherlands)

    Baldwin, David S.; den Boer, Johan A.; Lyndon, Gavin; Emir, Birol; Schweizer, Edward; Haswell, Hannah

    2015-01-01

    The aim of this review is to summarise the literature on the efficacy and safety of pregabalin for the treatment of generalised anxiety disorder (GAD). Of 241 literature citations, 13 clinical trials were identified that were specifically designed to evaluate the efficacy and safety of pregabalin in

  4. The Relationship Between Patient Safety Culture and Patient Outcomes: A Systematic Review.

    Science.gov (United States)

    DiCuccio, Margaret Hardt

    2015-09-01

    In the past 13 years since the Institute of Medicine report, To Err is Human, was published, considerable attention was placed on the relationship between patient safety culture and patient outcomes. Research to understand this relationship has been conducted; however, now, it is important to systematically review these studies to determine if there are tools, levels of measure and outcomes that have been shown to result in significant correlations. The purpose of this review is to evaluate the state of research connecting patient safety culture and patient outcomes to determine nurse-sensitive patient outcomes that have been significantly correlated to culture of safety and commonly used tools to measure culture of safety in the studies with significant correlations. Published English only research articles were considered for the review. Only studies that directly measured patient outcomes in relationship to patient safety culture in hospitals involving registered nurses as a participant were included. Evidence of relationships between patient safety culture and patient outcomes exist at the hospital and nursing unit level of analysis; however, the number of studies finding statistically significant correlations particularly using nurse-sensitive outcomes is limited. The findings from this review suggest that there are emerging trends indicating that the specific patient safety culture measurement tools, the level of analysis, and selection of outcome measures are important considerations in study design. More research is needed to determine interventions that improve patient safety culture and outcomes.

  5. 49 CFR 194.121 - Response plan review and update procedures.

    Science.gov (United States)

    2010-10-01

    ... as a change from crude oil to gasoline; (4) The name of the oil spill removal organization; (5... SAFETY RESPONSE PLANS FOR ONSHORE OIL PIPELINES Response Plans § 194.121 Response plan review and update... address such a change and, within 30 days of making such a change, submit the change to PHMSA. Examples of...

  6. Review of Studies on Pedestrian and Bicyclist Safety, 1991-2007

    Science.gov (United States)

    2012-06-01

    This report reviews the pedestrian and bicyclist safety research literature in print as of 2007. It summarizes and synthesizes the key studies, evaluates existing knowledge and identifies research gaps and provides recommendations for future directio...

  7. Investigation of practices and procedures in the use of therapeutic diathermy: a study from the physiotherapists' health and safety perspective.

    Science.gov (United States)

    Shah, Syed Ghulam Sarwar; Farrow, Alexandra

    2007-12-01

    The safe use of therapeutic diathermy requires practices and procedures that ensure compliance to professional guidelines and clinical evidence. Inappropriate use may expose physiotherapists and other people in the vicinity of operating diathermy devices to stray radiofrequency electromagnetic fields, which can be a source of risk and may lead to adverse health effects. The aim of the present study was to investigate practices and procedures for therapeutic diathermy from a health and safety perspective. A cross-sectional research design was used, this included a postal survey using a self-administered questionnaire and semi-structured observational visits to 46 physiotherapy departments in National Health Service (NHS) hospitals located in the south-east and south-west of England, including Greater London. Microwave diathermy was not available in the departments surveyed. Pulsed shortwave diathermy was available and was used more commonly than continuous shortwave diathermy. There were metallic objects in treatment cubicles used for pulsed shortwave diathermy and continuous shortwave diathermy. Shortwave diathermy devices created electromagnetic interference with a variety of electrical and medical devices. Physiotherapists reported that they did not stay in the treatment cubicle during the entire period of electrotherapy with pulsed shortwave diathermy or continous shortwave diathermy; pregnant physiotherapists reported that they did not use these devices. Electrotherapy with pulsed shortwave diathermy and continuous shortwave diathermy was not always administered on a wooden couch or chair. Electrotherapy was highest in those departments with the fewest physiotherapists. Departments report good practices and procedures regarding the use of therapeutic diathermy devices. However, field observations of practices and procedures, and the working environment, have identified issues with a potential to create health and safety problems, and these should be addressed

  8. Draft safety review plan for accelerator production of tritium (APT) project

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-07-01

    The purpose of this ``living`` Safety Review Plan (SRP) is to describe the products and processes that will be followed to conduct a systematic review of the Accelerator Production of Tritium (APT) Facility Preliminary Safety Analysis Report (PSAR), and subsequently to prepare a draft Safety Evaluation Report (SER) on the PSAR. This plan is prepared for and will be implemented by the APT Independent Safety Review Committee (ISRC) over the period July 1, 1997 through September 30, 1998, in accordance with provisions established in DOE-STD-1104-96. A core team of DOE, INEEL, and AMPARO Corporation engineers and scientists will prepare the initial draft SER with assistance from other ISRC team members on an as needed basis. Guidelines for preparing the draft SER are presented in Section 7 of this SRP. The PSAR reviews will focus exclusively on safety. The ever-present two-part question will be: Does the subject matter have safety significance? If so, does the APT structural, system, component, and/or process engineering design ensure an acceptable margin of safety? The APT mission, efficiency, and cost are not considerations of this plan. A more detailed discussion of the review philosophy is presented in Section 5 of this SRP.

  9. [Safety considerations to avoid current-induced skin burns in MRI procedures].

    Science.gov (United States)

    Knopp, M V; Metzner, R; Brix, G; van Kaick, G

    1998-09-01

    The safety aspects of radiological methods continue to evolve. In this paper we report on two cases of skin burns in MRI caused by induced electrical current. A second- and a third-degree skin burn occurred during imaging in a 1.5 T system. The electromagnetic radiofrequency field inadvertently led to electrical currents caused by a conducting loop through the extremities and trunk. Skin burns induced by electrical current may occur in extremely rare cases even with standard MR imaging protocols operating within all current safety guidelines by inadvertently forming a closed conducting loop. By avoiding focal skin to skin contact of the extremities, this extremely rare adverse event can be avoided.

  10. Looking at plastic surgery through Google Glass: part 1. Systematic review of Google Glass evidence and the first plastic surgical procedures.

    Science.gov (United States)

    Davis, Christopher R; Rosenfield, Lorne K

    2015-03-01

    Google Glass has the potential to become a ubiquitous and translational technological tool within clinical plastic surgery. Google Glass allows clinicians to remotely view patient notes, laboratory results, and imaging; training can be augmented via streamed expert master classes; and patient safety can be improved by remote advice from a senior colleague. This systematic review identified and appraised every Google Glass publication relevant to plastic surgery and describes the first plastic surgical procedures recorded using Google Glass. A systematic review was performed using PubMed National Center for Biotechnology Information, Ovid MEDLINE, and the Cochrane Central Register of Controlled Trials, following modified Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Key search terms "Google" and "Glass" identified mutually inclusive publications that were screened for inclusion. Eighty-two publications were identified, with 21 included for review. Google Glass publications were formal articles (n = 3), editorial/commentary articles (n = 7), conference proceedings (n = 1), news reports (n = 3), and online articles (n = 7). Data support Google Glass' positive impact on health care delivery, clinical training, medical documentation, and patient safety. Concerns exist regarding patient confidentiality, technical issues, and limited software. The first plastic surgical procedure performed using Google Glass was a blepharoplasty on October 29, 2013. Google Glass is an exciting translational technology with the potential to positively impact health care delivery, medical documentation, surgical training, and patient safety. Further high-quality scientific research is required to formally appraise Google Glass in the clinical setting.

  11. Improving patient safety in image-based procedures : Bridging the gap between preferred and actual proficiency

    NARCIS (Netherlands)

    Buzink, S.N.

    2010-01-01

    For patients less invasive image-based procedures (IBP) such as laparoscopy have many benefits in comparison to traditional open surgery, such as less pain, faster recovery, and fewer scars. However, to perform IBP effectively, efficiently, and above all safely, the surgical team is highly dependent

  12. Risk and safety requirements for diagnostic and therapeutic procedures in allergology

    DEFF Research Database (Denmark)

    Kowalski, Marek L; Ansotegui, Ignacio; Aberer, Werner

    2016-01-01

    dangerous reactions, which in many instances cannot be completely avoided. However, adverse reactions can be minimized or even avoided if a physician is fully aware of potential risk and is prepared to appropriately handle the situation. Information on the risk of diagnostic and therapeutic procedures...

  13. SAFETY

    CERN Multimedia

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  14. Patient participation in patient safety and nursing input - a systematic review.

    Science.gov (United States)

    Vaismoradi, Mojtaba; Jordan, Sue; Kangasniemi, Mari

    2015-03-01

    This systematic review aims to synthesise the existing research on how patients participate in patient safety initiatives. Ambiguities remain about how patients participate in routine measures designed to promote patient safety. Systematic review using integrative methods. Electronic databases were searched using keywords describing patient involvement, nursing input and patient safety initiatives to retrieve empirical research published between 2007 and 2013. Findings were synthesized using the theoretical domains of Vincent's framework for analysing risk and safety in clinical practice: "patient", "healthcare provider", "task", "work environment", "organisation & management". We identified 17 empirical research papers: four qualitative, one mixed-method and 12 quantitative designs. All 17 papers indicated that patients can participate in safety initiatives. Improving patient participation in patient safety necessitates considering the patient as a person, the nurse as healthcare provider, the task of participation and the clinical environment. Patients' knowledge, health conditions, beliefs and experiences influence their decisions to engage in patient safety initiatives. An important component of the management of long-term conditions is to ensure that patients have sufficient knowledge to participate. Healthcare providers may need further professional development in patient education and patient care management to promote patient involvement in patient safety, and ensure that patients understand that they are 'allowed' to inform nurses of adverse events or errors. A healthcare system characterised by patient-centredness and mutual acknowledgement will support patient participation in safety practices. Further research is required to improve international knowledge of patient participation in patient safety in different disciplines, contexts and cultures. Patients have a significant role to play in enhancing their own safety while receiving hospital care. This

  15. Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation

    Directory of Open Access Journals (Sweden)

    Edmund H. Jooste

    2017-08-01

    Full Text Available Dexmedetomidine (Precedex™ may be used as an alternative sedative in children, maintaining spontaneous breathing, and avoiding tracheal intubation in a non-intubated moderate or deep sedation (NI-MDS approach. This open-label, single-arm, multicenter study evaluated the safety of dexmedetomidine in a pediatric population receiving NI-MDS in an operating room or a procedure room, with an intensivist or anesthesiologist in attendance, for elective diagnostic or therapeutic procedures expected to take at least 30 min. The primary endpoint was incidence of treatment-emergent adverse events (TEAEs. Patients received one of two doses dependent on age: patients aged ≥28 weeks' gestational age to <1 month postnatal received dose level 1 (0.1 μg/kg load; 0.05–0.2 μg/kg/h infusion; those aged 1 month to <17 years received dose level 2 (1 μg/kg load; 0.2–2.0 μg/kg/h infusion. Sedation efficacy was assessed and defined as adequate sedation for at least 80% of the time and successful completion of the procedure without the need for rescue medication. In all, 91 patients were enrolled (dose level 1, n = 1; dose level 2, n = 90; of these, 90 received treatment and 82 completed the study. Eight patients in dose level 2 discontinued treatment for the following reasons: early completion of diagnostic or therapeutic procedure (n = 3; change in medical condition (need for intubation requiring deeper level of sedation (n = 2; adverse event (AE; hives and emesis, lack of efficacy, and physician decision (patient not sedated enough to complete procedure; n = 1 each. Sixty-seven patients experienced 147 TEAEs. The two most commonly reported AEs were respiratory depression (bradypnea; reported per protocol-defined criteria, based on absolute respiratory rate values for age or relative decrease of 30% from baseline and hypotension. Four patients received glycopyrrolate for bradycardia and seven patients received intravenous fluids for hypotension. SpO2

  16. Safety Behaviors in Adults With Social Anxiety: Review and Future Directions.

    Science.gov (United States)

    Piccirillo, Marilyn L; Taylor Dryman, M; Heimberg, Richard G

    2016-09-01

    Safety behaviors are considered an important factor in the maintenance of social anxiety disorder (SAD). Safety behaviors are typically employed by socially anxious individuals to reduce anxiety in feared social situations. However, by preventing individuals with social anxiety from gathering evidence that would disconfirm their maladaptive beliefs about social situations, the use of safety behaviors ultimately maintains social anxiety over time. Twenty years ago, Wells and colleagues (1995) demonstrated that use of safety behaviors diminishes the efficacy of exposure treatment for SAD, suggesting that reduction in the use of safety behaviors during exposure can enhance treatment response. Research on safety behaviors has expanded considerably since Wells et al.'s seminal publication, and our understanding of the role safety behaviors may play in the maintenance of social anxiety has grown in breadth and depth. In this paper, we present a detailed review of the published research on safety behaviors relevant to social anxiety and social-anxiety-related processes. Finally, we evaluate the impact of safety behaviors on the outcome of treatment for SAD, and we look to the literature on safety behaviors in other anxiety disorders to inform our understanding of use of safety behaviors during exposure and to facilitate future research in SAD. Copyright © 2015. Published by Elsevier Ltd.

  17. Aviation and healthcare: a comparative review with implications for patient safety

    Science.gov (United States)

    Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

    2015-01-01

    Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing. PMID:26770817

  18. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty

    DEFF Research Database (Denmark)

    Fischer, H.B.; Simanski, C.J.; Sharp, C.

    2008-01-01

    The PROSPECT Working Group, a collaboration of anaesthetists and surgeons, conducts systematic reviews of postoperative pain management for different surgical procedures (http://www.postoppain.org). Evidence-based consensus recommendations for the effective management of postoperative pain...... are then developed from these systematic reviews, incorporating clinical practice observations, and transferable evidence from other relevant procedures. We present the results of a systematic review of pain and other outcomes following analgesic, anaesthetic and surgical interventions for total knee arthroplasty...... (TKA). The evidence from this review supports the use of general anaesthesia combined with a femoral nerve block for surgery and postoperative analgesia, or alternatively spinal anaesthesia with local anaesthetic plus spinal morphine. The primary technique, together with cooling and compression...

  19. Procedural learning across the lifespan: A systematic review with implications for atypical development.

    Science.gov (United States)

    Zwart, Fenny S; Vissers, Constance Th W M; Kessels, Roy P C; Maes, Joseph H R

    2017-10-08

    This systematic review aimed to investigate procedural learning across the lifespan in typical and atypical development. Procedural learning is essential for the development of everyday skills, including language and communication skills. Although procedural learning efficiency has been extensively studied, there is no consensus yet on potential procedural learning changes during development and ageing. Currently, three conflicting models regarding this trajectory exist: (1) a model of age invariance; (2a) a model with a peak in young adulthood; and (2b) a model with a plateau in childhood followed by a decline. The aims of this study were (1) to investigate this debate on procedural learning across the lifespan by systematically reviewing evidence for each model from studies using the serial reaction time task; and (2) to review procedural learning in autism spectrum disorder (ASD) and specific language impairment (SLI), two developmental disorders characterized by deficits in communication skills, in the light of these models. Our findings on typical development strongly support a model of age-related changes (Model 2a or 2b) and show that mixed findings regarding the developmental trajectory during childhood can be explained by methodological differences across studies. Applying these conclusions to systematic reviews of studies of ASD and SLI makes it clear that there is a strong need for the inclusion of multiple age groups in these clinical studies to model procedural learning in atypical development. Clinical implications of the findings are discussed. Future research should focus on the role of declarative learning in both typical and atypical development. © 2017 The British Psychological Society.

  20. Energy Storage System Safety: Plan Review and Inspection Checklist

    Energy Technology Data Exchange (ETDEWEB)

    Cole, Pam C (PNNL); Conover, David R (PNNL)

    2017-03-01

    Codes, standards, and regulations (CSR) governing the design, construction, installation, commissioning, and operation of the built environment are intended to protect the public health, safety, and welfare. While these documents change over time to address new technology and new safety challenges, there is generally some lag time between the introduction of a technology into the market and the time it is specifically covered in model codes and standards developed in the voluntary sector. After their development, there is also a timeframe of at least a year or two until the codes and standards are adopted. Until existing model codes and standards are updated or new ones are developed and then adopted, one seeking to deploy energy storage technologies or needing to verify the safety of an installation may be challenged in trying to apply currently implemented CSRs to an energy storage system (ESS). The Energy Storage System Guide for Compliance with Safety Codes and Standards1 (CG), developed in June 2016, is intended to help address the acceptability of the design and construction of stationary ESSs, their component parts, and the siting, installation, commissioning, operations, maintenance, and repair/renovation of ESS within the built environment.

  1. Gender issues in safety and health at work : a review

    NARCIS (Netherlands)

    Houtman, I.L.D.; Kauppinen, K.; Kumpulainen, R.; Goudswaard, A.

    2003-01-01

    This report explores the gender differences in occupational safety and health. There is strong segregation of women and men into different jobs and tasks at work. Both men and women face significant risks. In general, men suffer more accidents and injuries at work than women do, whereas women report

  2. Review of the World Bank Road Safety website.

    NARCIS (Netherlands)

    Maas, J.M.

    2006-01-01

    The Road Safety website of The World Bank needs to be redeveloped. The website should reflect the new developments in the work field and the IT policy of The World Bank and support its implementation. The report is meant as a brief business case, describing the target audience, purposes of the site,

  3. Occupational Health and Safety in Ethiopia: A review of Situational ...

    African Journals Online (AJOL)

    Background: The current rapid economic development has brought changes in workplaces in developing countries, including Ethiopia. The organization of occupational health and safety services is not yet resilient enough to handle the growing demands for workers' health in the context of industrialization. There is limited ...

  4. Review of studies and guidelines on fasting and procedural sedation at the emergency department.

    Science.gov (United States)

    Molina, Joseph Antonio D; Lobo, Cheryl A; Goh, Hsin Kai; Seow, Eillyne; Heng, Bee Hoon

    2010-06-01

    Procedural sedation and analgesia allows urgent procedures to be performed safely by preserving patients' airway reflexes. Fasting, which is required before deeper levels of sedation, and where the airway reflexes are not preserved, is difficult to impose in emergencies. This paper aims to synthesise evidence on the need for pre-procedure fasting to minimise aspiration among adults undergoing procedural sedation and analgesia for emergency procedures. Overviews, guidelines with graded recommendations and primary studies on aspiration and pre-procedure fasting in procedural sedation and analgesia were retrieved from Medline, Cochrane, and Center for Reviews and Dissemination Databases. Terms searched were procedural sedation, fasting, emergency and sedation. One primary study and one guideline were included. The American College of Emergency Physicians Clinical Policies Subcommittee on Procedural Sedation and Analgesia issued a recommendation based on 'preliminary, inconclusive or conflicting evidence, or on panel consensus'. The recommendation states: 'recent food intake is not a contraindication for administering procedural sedation and analgesia...'. The primary study conducted by Bell in an emergency department in Australia compared patients who last ate or drank more than 6 and 2 h from induction, respectively, with those who last ate or drank within 6 and 2 h. There were no cases of aspiration in both groups. Out of 118 patients who fasted, 1 (0.8%) vomited, as did one of 282 patients (0.4%) who did not fast. Aspiration risk is expected to be lower in procedural sedation and analgesia than in general anaesthesia. Current guidelines rely on expert consensus due to the lack of primary studies. Contextualisation of existing guidelines are quick and efficient strategies for developing locally relevant tools. © 2010 The Authors. Journal Compilation © Blackwell Publishing Asia Pty Ltd.

  5. Effect of Music on Outpatient Urological Procedures: A Systematic Review and Meta-Analysis from ESUT.

    Science.gov (United States)

    Kyriakides, Rena; Jones, Patrick; Geraghty, Robert; Skolarikos, Andreas; Liatsikos, Evangellos; Traxer, Olivier; Pietropaolo, Amelia; Somani, Bhaskar K

    2017-12-07

    Music is a practical, inexpensive and harmless analgesic and anxiolytic. An increasing number of original studies have been performed to investigate its potential application in urology. Our aim was to identify the effect of music on outpatient based urological procedures. We systematically reviewed the effect of using music during all reported outpatient urology procedures, including transrectal ultrasound guided prostate biopsy, shock wave lithotripsy, urodynamic studies, percutaneous nephrostomy tube placement and cystoscopy. Data were included on all randomized trials from 1980 to 2017 and no language restrictions were applied. Included in analysis were 16 randomized studies in which 972 of 1,950 patients (49.8%) were exposed to music during an outpatient procedure. The procedures included transrectal ultrasound guided prostate biopsy in 4 studies in a total of 286 patients, shock wave lithotripsy in 6 studies in a total of 1023, cystoscopy in 3 studies in a total of 331, urodynamics in 2 studies in a total of 210 and percutaneous nephrostomy in 1 study in a total of 100. All studies incorporated a visual analog score to measure pain. Anxiety was measured by STAI (State-Trait anxiety Inventory) in 13 studies and by a visual analog scale in 2. While 14 of the 16 studies showed a reduction in self-reported pain, a reduction in anxiety was seen in 14. When using music, overall procedural satisfaction was better in 9 studies and patient willingness to repeat the procedure was also higher in 7. Our meta-analysis revealed a significant reduction in visual analog scale and STAI findings across all studies (p <0.001). Our systematic review demonstrated a beneficial effect of music on urological outpatient procedures. Music seemed to decrease anxiety and pain. It might serve as a useful adjunct to increase procedural satisfaction and patient willingness to undergo the procedure again. Copyright © 2018 American Urological Association Education and Research, Inc

  6. 76 FR 58846 - Final Interim Staff Guidance: Review of Evaluation To Address Gas Accumulation Issues in Safety...

    Science.gov (United States)

    2011-09-22

    ... COMMISSION Final Interim Staff Guidance: Review of Evaluation To Address Gas Accumulation Issues in Safety...-ISG-019 on ``Review of Evaluation to Address Gas Accumulation Issues in Safety Related Systems... is to clarify the NRC staff guidance to address issues of gas accumulation in safety related systems...

  7. 49 CFR 385.311 - What will the safety audit consist of?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false What will the safety audit consist of? 385.311... SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.311 What will the safety audit consist of? The safety audit will consist of a review of the new entrant's safety management systems and a...

  8. Review of the regulation and safety assessment of food substances in various countries and jurisdictions.

    Science.gov (United States)

    Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan

    2013-01-01

    This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods.

  9. Improving the governance of patient safety in emergency care: a systematic review of interventions

    NARCIS (Netherlands)

    Hesselink, G.J.; Berben, S.A.; Beune, T.; Schoonhoven, L.

    2016-01-01

    OBJECTIVES: To systematically review interventions that aim to improve the governance of patient safety within emergency care on effectiveness, reliability, validity and feasibility. DESIGN: A systematic review of the literature. METHODS: PubMed, EMBASE, Cumulative Index to Nursing and Allied Health

  10. 77 FR 36532 - Review of Small Generator Interconnection Agreements and Procedures; Solar Energy Industries...

    Science.gov (United States)

    2012-06-19

    ...-001; ER12-1855-000] Review of Small Generator Interconnection Agreements and Procedures; Solar Energy....gov/whats-new/registration/small-generator-7-17-12-form.asp . The purpose of this conference is to discuss issues related to a petition for rulemaking recently submitted by the Solar Energy Industries...

  11. THE NEGATIVE EFFECTS OF SOME COSMETIC PROCEDURES: PROTECTION POSSIBILITIES, MEDICAL AND PREVENTIVE AGENTS (REVIEW

    Directory of Open Access Journals (Sweden)

    A. V. Majorova

    2016-01-01

    Full Text Available The article describes the possible side responses on cosmetic procedures. There is a review of pharmaceutical and cosmeceutical agents for external use to treat and prevent the complications. We have described the reasonability of the external dosage forms use of anti-histaminic action.

  12. 78 FR 19268 - Subcommittee on Procedures Review, Advisory Board on Radiation and Worker Health (ABRWH...

    Science.gov (United States)

    2013-03-29

    ... subcommittee: Time and Date: 10:30 a.m.-5:00 p.m., April 25, 2013. Place: Audio Conference Call via FTS... contact person below in advance of the meeting. Background: The ABRWH was established under the Energy.... The Subcommittee on Procedures Review is responsible for overseeing, tracking, and participating in...

  13. 78 FR 62635 - Subcommittee on Procedures Review, Advisory Board on Radiation and Worker Health (ABRWH...

    Science.gov (United States)

    2013-10-22

    ... subcommittee: Time and Date: 11:00 a.m.-5:00 p.m. Eastern Time, November 7, 2013. Place: Audio Conference Call..., tracking, and participating in the reviews of all procedures used in the dose reconstruction process by the... provided at the meeting and should be submitted to the contact person below in advance of the meeting...

  14. A qualitative analysis of the determinants in the choice of a French journal reviewing procedures

    Science.gov (United States)

    Morge, Ludovic

    2015-12-01

    Between 1993 and 2010, two French journals (Aster and Didaskalia) coming from different backgrounds but belonging to the same institution used to publish papers on research in science and technology education. The merging of these journals made it necessary for them to compare the different reviewing procedures used by each. This merging occurred at a time when research is becoming increasingly international which partly determines some of the reviewing procedure choices. In order for a francophone international journal to survive, it needs to take this internationalization into account in a reasoned manner. The author of this article, as a chief editor of RDST (Recherches en Didactique des Sciences et des Technologies)—the journal resulting from the merging- taking part in this merger, analyses the social, cultural and pragmatic determinants which impacted the choices made in reviewing procedures. This paper describes how these diversity of factors leads us to drop the idea of a standard reviewing procedure which would be valid for all journals.

  15. Physical Restraint of People with Intellectual Disability: A Review of Implementation Reduction and Elimination Procedures

    Science.gov (United States)

    Luiselli, James K.

    2009-01-01

    Background: This review describes procedures to reduce and eliminate physical restraint of people with intellectual disability. One approach is to assess antecedent conditions associated with restraint and change them so that they no longer produce restraint-provoking behaviour. A second approach is to decrease the duration of restraint by…

  16. Idaho National Laboratory Integrated Safety Management System 2010 Effectiveness Review and Declaration Report

    Energy Technology Data Exchange (ETDEWEB)

    Thomas J. Haney

    2010-12-01

    Idaho National Laboratory completes an annual Integrated Safety Management System effectiveness review per 48 CFR 970.5223-1 “Integration of Environment, Safety and Health into Work Planning and Execution.” The annual review assesses ISMS effectiveness, provides feedback to maintain system integrity, and helps identify target areas for focused improvements and assessments for the following year. Using one of the three Department of Energy (DOE) descriptors in DOE M 450.4-1 regarding the state of ISMS effectiveness during Fiscal Year (FY) 2010, the information presented in this review shows that INL achieved “Effective Performance.”

  17. Demographic, procedural and 30-day safety results from the WEB Intra-saccular Therapy Study (WEB-IT).

    Science.gov (United States)

    Fiorella, David; Molyneux, Andrew; Coon, Alexander; Szikora, Istvan; Saatci, Isil; Baltacioglu, Feyyaz; Sultan, Ali; Arthur, Adam

    2017-12-01

    The Woven EndoBridge (WEB) represents a novel intrasaccular therapeutic option for the treatment of intracranial wide-necked bifurcation aneurysms (WNBAs). The WEB-IT Study is a pivotal Investigational Device Exemption (IDE) study to determine the safety and effectiveness of the WEB device for the treatment of WNBAs located in the anterior and posterior intracranial circulations. We present the patient demographics, procedural characteristics, and 30-day adverse event data for the US WEB-IT study. WEB-IT is a prospective multicenter single-arm interventional study conducted at 25 US and 6 international centers. The study enrolled 150 adults with WNBAs of the anterior and posterior intracranial circulations. All patients were intended to receive a WEB device delivered via standard endovascular neurosurgical embolization techniques. The study was conducted under Good Clinical Practices and included independent adjudication effectiveness outcomes and all adverse events. One hundred and fifty patients enrolled at 27 investigational sites underwent attempted treatment with the WEB. Mean age was 59 years (range 29-79) and 110 (73.3%) of the patients were female. Treated aneurysms were located at the basilar apex (n=59, 39.3%), middle cerebral artery bifurcation (n=45, 30%), anterior communicating artery (n=40, 26.7%), and internal carotid artery terminus (n=6, 4%). Average aneurysm size was 6.4 mm (range 3.6-11.4) with a mean neck size of 4.8 mm (range 2.0-8.2, mean dome to neck ratio 1.34). Nine patients presented with ruptured aneurysms. Of the enrolled patients, 98.7% were treated successfully with WEB devices. Mean±SD fluoroscopy time was 30.2±15.7 min. One primary safety event (PSE) (0.7%)-a delayed parenchymal hemorrhage 22 days after treatment-occurred between the index procedure and 30-day follow-up. In addition to the single PSE, there were seven (4.7%) minor ischemic strokes (5 resolved without sequelae and 2 had a modified Rankin Scale score of 1

  18. A 100-Year Review: Microbiology and safety of milk handling.

    Science.gov (United States)

    Boor, Kathryn J; Wiedmann, Martin; Murphy, Sarah; Alcaine, Sam

    2017-12-01

    Microbes that may be present in milk can include pathogens, spoilage organisms, organisms that may be conditionally beneficial (e.g., lactic acid bacteria), and those that have not been linked to either beneficial or detrimental effects on product quality or human health. Although milk can contain a full range of organisms classified as microbes (i.e., bacteria, viruses, fungi, and protozoans), with few exceptions (e.g., phages that affect fermentations, fungal spoilage organisms, and, to a lesser extent, the protozoan pathogens Cryptosporidium and Giardia) dairy microbiology to date has focused predominantly on bacteria. Between 1917 and 2017, our understanding of the microbes present in milk and the tools available for studying those microbes have changed dramatically. Improved microbiological tools have enabled enhanced detection of known microbes in milk and dairy products and have facilitated better identification of pathogens and spoilage organisms that were not known or well recognized in the early 20th century. Starting before 1917, gradual introduction and refinement of pasteurization methods throughout the United States and many other parts of the world have improved the safety and quality of milk and dairy products. In parallel to pasteurization, others strategies for reducing microbial contamination throughout the dairy chain (e.g., improved dairy herd health, raw milk tests, clean-in-place technologies) also played an important role in improving microbial milk quality and safety. Despite tremendous advances in reducing microbial food safety hazards and spoilage issues, the dairy industry still faces important challenges, including but not limited to the need for improved science-based strategies for safety of raw milk cheeses, control of postprocessing contamination, and control of sporeforming pathogens and spoilage organisms. Copyright © 2017 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  19. Efficacy and safety of blonanserin versus other antipsychotics: a review

    OpenAIRE

    Anant D. Patil

    2013-01-01

    Although many atypical antipsychotics are available, there is a need of an atypical antipsychotic effective in all symptom domains of schizophrenia and well tolerated especially for side effects like extrapyramidal side effects, weight gain and blood prolactin elevation. Blonanserin is an atypical antipsychotic which blocks dopamine D2 and serotonin 5HT2A receptors. Its efficacy and safety has been studied in patients with schizophrenia and delirium. Blonanserin is found to be effective and w...

  20. Donor safety in live donor laparoscopic liver procurement: systematic review and meta-analysis.

    Science.gov (United States)

    Bekheit, Mohamed; Khafagy, Philipe-Abrahim; Bucur, Petru; Katri, Khaled; Elgendi, Ahmed; Abdel-Salam, Wael Nabil; Vibert, Eric; El-Kayal, El-Said

    2015-11-01

    Donor safety is a major concern in live organ donation. Live donor laparoscopic liver procurement is an advanced surgical procedure that is performed in highly specialized centers. Since its first report, not much progress has been endeavored for that procedure. We planned to include all the randomized and comparative nonrandomized studies. Patients' population: live donors who are submitted to organ procurement via laparoscopy. Out of 5,636 records retrieved from the literature, only seven nonrandomized studies were included in this review, which encompassed 418 patients, 151 patients of whom underwent laparoscopic procurement. The quality scores for the included studies ranged from 66 to 76 %. The operative time was significantly shorter in the conventional open group (SD = 0.863, 95 % CI 0.107-1.819). Blood loss in the laparoscopic group was comparable with the conventional open approach (SD = -0.307, 95 % CI -0.807 to 0.192). In subgroup analysis, laparoscopy was protective against blood loss in laparoscopic parenchymal dissection (SD = -1.168, 95 % CI -1.758 to -0.577). The hospital stay was equal in both groups. Patients in laparoscopic group consumed fewer analgesics compared with conventional open group (SD = -0.33, 95 % CI -0.63 to -0.03). Analgesics use was lower in the laparoscopic group compared with the conventional approach. The rate of Clavien complications was equal in both groups (OR 0.721, 95 % CI 0.303-1.716). No difference was found between subgroup analysis based on the harvested liver lobe. Funnel plot and statistical methods used revealed low probability of publication BIAS. Live donor laparoscopic liver procurement could be as safe as the conventional open approach. Lower blood loss and lower consumtion of analgesics might be offered in the laparoscopic approach.

  1. Systematic psychometric review of self-reported instruments to assess patient safety culture in primary care.

    Science.gov (United States)

    Desmedt, Melissa; Bergs, Jochen; Vertriest, Sonja; Vlayen, Annemie; Schrooten, Ward; Hellings, Johan; Vandijck, Dominique

    2017-09-27

    To give an overview of empirical studies using self-reported instruments to assess patient safety culture in primary care and to synthesize psychometric properties of these instruments. A key condition for improving patient safety is creating a supportive safety culture to identify weaknesses and to develop improvement strategies so recurrence of incidents can be minimized. However, most tools to measure and strengthen safety culture have been developed and tested in hospitals. Nevertheless, primary care is facing greater risks and a greater likelihood of causing unintentional harm to patients. A systematic literature review of research evidence and psychometric properties of self-reported instruments to assess patient safety culture in primary care. Three databases until November 2016. The review was carried out according to the protocol for systematic reviews of measurement properties recommended by the COSMIN panel and the PRISMA reporting guidelines. In total, 1.229 records were retrieved from multiple database searches (Medline = 865, Web of Science = 362 and Embase = 2). Resulting from an in-depth literature search, 14 published studies were identified, mostly originated from Western high-income countries. As these studies come with great diversity in tools used and outcomes reported, comparability of the results is compromised. Based on the psychometric review, the SCOPE-Primary Care survey was chosen as the most appropriate instrument to measure patient safety culture in primary care as the instrument had excellent internal consistency with Cronbach's alphas ranging from 0.70-0.90 and item factor loadings ranging from 0.40-0.96, indicating a good structural validity. The findings of the present review suggest that the SCOPE-Primary Care survey is the most appropriate tool to assess patient safety culture in primary care. Further psychometric techniques are now essential to ensure that the instrument provides meaningful information regarding safety

  2. The use of multimedia consent programs for surgical procedures: a systematic review.

    Science.gov (United States)

    Nehme, Jean; El-Khani, Ussamah; Chow, Andre; Hakky, Sherif; Ahmed, Ahmed R; Purkayastha, Sanjay

    2013-02-01

    To compare multimedia and standard consent, in respect to patient comprehension, anxiety, and satisfaction, for various surgical/interventional procedures. Electronic searches of PubMed, MEDLINE, Ovid, Embase, and Google Scholar were performed. Relevant articles were assessed by 2 independent reviewers. Comparative (randomized and nonrandomized control trials) studies of multimedia and standard consent for a variety of surgical/interventional procedures were included. Studies had to report on at least one of the outcome measures. Studies were reviewed by 2 independent investigators. The first investigator extracted all relevant data, and consensus of each extraction was performed by a second investigator to verify the data. Overall, this review suggests that the use of multimedia as an adjunct to conventional consent appears to improve patient comprehension. Multimedia leads to high patient satisfaction in terms of feasibility, ease of use, and availability of information. There is no conclusive evidence demonstrating a significant reduction in preoperative anxiety.

  3. Idaho National Laboratory Integrated Safety Management System FY 2012 Effectiveness Review and Declaration Report

    Energy Technology Data Exchange (ETDEWEB)

    Farren Hunt

    2012-12-01

    Idaho National Laboratory (INL) performed an Annual Effectiveness Review of the Integrated Safety Management System (ISMS), per 48 Code of Federal Regulations (CFR) 970.5223 1, “Integration of Environment, Safety and Health into Work Planning and Execution.” The annual review assessed Integrated Safety Management (ISM) effectiveness, provided feedback to maintain system integrity, and identified target areas for focused improvements and assessments for fiscal year (FY) 2013. Results of the FY 2012 annual effectiveness review demonstrated that the INL’s ISMS program was significantly strengthened. Actions implemented by the INL demonstrate that the overall Integrated Safety Management System is sound and ensures safe and successful performance of work while protecting workers, the public, and environment. This report also provides several opportunities for improvement that will help further strengthen the ISM Program and the pursuit of safety excellence. Demonstrated leadership and commitment, continued surveillance, and dedicated resources have been instrumental in maturing a sound ISMS program. Based upon interviews with personnel, reviews of assurance activities, and analysis of ISMS process implementation, this effectiveness review concludes that ISM is institutionalized and is “Effective”.

  4. Strategies for improving patient safety culture in hospitals: a systematic review.

    Science.gov (United States)

    Morello, Renata Teresa; Lowthian, Judy A; Barker, Anna Lucia; McGinnes, Rosemary; Dunt, David; Brand, Caroline

    2013-01-01

    To determine the effectiveness of patient safety culture strategies to improve hospital patient safety climate. Electronic search of the Cochrane Library, OVID Medline, Embase, CINAHL, proQuest and psychinfo databases, with manual searches of quality and safety websites, bibliographies of included articles and key journals. English language studies published between January 1996 and April 2011 that measured the effectiveness of patient safety culture strategies using a quantitative measure of patient safety climate in a hospital setting. Studies included were randomised controlled trials (RCTs), non-RCTs, controlled before and after studies, interrupted time series and historically controlled studies. Data extraction and critical appraisal were conducted by two independent reviewers. Study design, intervention, level of application, setting, study participants, safety climate outcome measures and implementation lessons were extracted from each article. Over 2000 articles were screened, with 21 studies meeting the inclusion criteria, one cluster RCT, seven controlled before and after studies, and 13 historically controlled studies. There was marked methodological heterogeneity amongst studies. Impacts of 11 different strategies were reported. There was some evidence to support that leadership walk rounds (p=0.02) and multi-faceted unit-based programmes (p < 0.05) may have a positive impact on patient safety climate. Despite strong face validity for a variety of patient safety culture strategies, there is limited evidence to support definitive impacts on patient safety climate outcomes. Organisations are advised to consider robust evaluation designs when implementing these potentially resource intensive strategies.

  5. Humeral lengthening in patients with achondroplasia and in patients with post-septic shortening: comparison of procedure efficiency and safety.

    Science.gov (United States)

    Shadi, Milud; Musielak, Bartosz; Koczewski, Paweł; Janusz, Piotr

    2018-02-01

    Although humeral lengthening in patients with achondroplasia is an accepted procedure for improving functional status, there is still a paucity of information about the effectiveness of the method. Therefore, the aim of this study was to evaluate the efficacy and safety of humeral lengthening using monolateral fixators in patients with achondroplasia and unilateral shortening. Twenty-one patients (31 humeri) were included in this study. The study group consisted of eight patients with achondroplasia (16 segments). The control group consisted of 13 patients with post-septic shortening of the humerus (15 segments). All subjects underwent distraction osteogenesis with the use of a monolateral fixator. The mean lengthening in the patients with achondroplasia was 8.29 cm, whereas in the control group it was 7.34 cm (p = 0.1677). The mean lengthening percentage in the patients with achondroplasia (50% of the initial length of the humerus) was significantly greater than in the control group (33% of the initial length of the humerus) (p = 0.0007). The mean healing index was 24.8 days/cm in the patients with achondroplasia and 28.56 days/cm in the control group (p = 0.1832). The overall complication rates for the achondroplastic and post-septic patients were, respectively, 175% and 160% (p = 0.1420). Humeral lengthening with use of monolateral fixators in patients with achondroplasia is an efficient method. Although the segment lengthening percentage is significantly greater in patients with achondroplasia than in patients with post-septic shortening of the humerus, the safety of this procedure is comparable.

  6. Food Safety Evaluation Based on Near Infrared Spectroscopy and Imaging: A Review.

    Science.gov (United States)

    Fu, Xiaping; Ying, Yibin

    2016-08-17

    In recent years, due to the increasing consciousness of food safety and human health, much progress has been made in developing rapid and nondestructive techniques for the evaluation of food hazards, food authentication, and traceability. Near infrared (NIR) spectroscopy and imaging techniques have gained wide acceptance in many fields because of their advantages over other analytical techniques. Following a brief introduction of NIR spectroscopy and imaging basics, this review mainly focuses on recent NIR spectroscopy and imaging applications for food safety evaluation, including (1) chemical hazards detection; (2) microbiological hazards detection; (3) physical hazards detection; (4) new technology-induced food safety concerns; and (5) food traceability. The review shows NIR spectroscopy and imaging to be effective tools that will play indispensable roles for food safety evaluation. In addition, on-line/real-time applications of these techniques promise to be a huge growth field in the near future.

  7. Risk of bleeding associated with interventional musculoskeletal radiology procedures. A comprehensive review of the literature

    Energy Technology Data Exchange (ETDEWEB)

    Foremny, Gregory B.; Jose, Jean; Subhawong, Ty K. [University of Miami Miller School of Medicine, Department of Radiology, Jackson Memorial Hospital, Miami, FL (United States); Pretell-Mazzini, Juan [University of Miami Miller School of Medicine, Department of Orthopaedic Surgery-Division of Musculoskeletal Oncology, Miami, FL (United States)

    2015-05-01

    This review compiles the current literature on the bleeding risks in common musculoskeletal interventional procedures and attempts to provide guidance for practicing radiologists in making decisions regarding the periprocedural management of patients on antithrombotic therapy. The practitioner must weigh the risk of bleeding if therapy is continued against the possibility a thromboembolic occurring if anticoagulation therapy is withheld or reversed. Unfortunately, there is little empirical data to guide evidence-based decisions for many musculoskeletal interventions. However, a review of the literature shows that for low-risk procedures, such as arthrograms/arthrocenteses or muscle/tendon sheath injections, bleeding risks are sufficiently small that anticoagulants and antiplatelet therapies need not be withheld. Additionally, relatively higher-risk procedures, such as needle biopsies of bone and soft tissue, may be safely performed without holding antithrombotic therapy, provided pre-procedural INR is within therapeutic range. Thus, while a patient's particular clinical circumstances should dictate optimal individualized management, anticoagulation alone is not a general contraindication to most interventional musculoskeletal radiology procedures. (orig.)

  8. Dissemination of periodontal pathogens in the bloodstream after periodontal procedures: a systematic review.

    Directory of Open Access Journals (Sweden)

    Anna Carolina Ratto Tempestini Horliana

    Full Text Available BACKGROUND: To date, there is no compilation of evidence-based information associating bacteremia and periodontal procedures. This systematic review aims to assess magnitude, duration, prevalence and nature of bacteremia caused by periodontal procedures. STUDY DESIGN: Systematic Review. TYPES OF STUDIES REVIEWED: MEDLINE, EMBASE and LILACS databases were searched in duplicate through August, 2013 without language restriction. Observational studies were included if blood samples were collected before, during or after periodontal procedures of patients with periodontitis. The methodological quality was assessed in duplicate using the modified Newcastle-Ottawa scale (NOS. RESULTS: Search strategy identified 509 potentially eligible articles and nine were included. Only four studies demonstrated high methodological quality, whereas five were of medium or low methodological quality. The study characteristics were considered too heterogeneous to conduct a meta-analysis. Among 219 analyzed patients, 106 (49.4% had positive bacteremia. More frequent bacteria were S. viridans, A. actinomycetemcomitans P. gingivalis, M. micros and species Streptococcus and Actinomyces, although identification methods of microbiologic assays were different among studies. CLINICAL IMPLICATIONS: Although half of the patients presented positive bacteremia after periodontal procedures, accurate results regarding the magnitude, duration and nature of bacteremia could not be confidentially assessed.

  9. Dissemination of Periodontal Pathogens in the Bloodstream after Periodontal Procedures: A Systematic Review

    Science.gov (United States)

    Horliana, Anna Carolina Ratto Tempestini; Chambrone, Leandro; Foz, Adriana Moura; Artese, Hilana Paula Carillo; Rabelo, Mariana de Sousa; Pannuti, Cláudio Mendes; Romito, Giuseppe Alexandre

    2014-01-01

    Background To date, there is no compilation of evidence-based information associating bacteremia and periodontal procedures. This systematic review aims to assess magnitude, duration, prevalence and nature of bacteremia caused by periodontal procedures. Study Design Systematic Review Types of Studies Reviewed MEDLINE, EMBASE and LILACS databases were searched in duplicate through August, 2013 without language restriction. Observational studies were included if blood samples were collected before, during or after periodontal procedures of patients with periodontitis. The methodological quality was assessed in duplicate using the modified Newcastle-Ottawa scale (NOS). Results Search strategy identified 509 potentially eligible articles and nine were included. Only four studies demonstrated high methodological quality, whereas five were of medium or low methodological quality. The study characteristics were considered too heterogeneous to conduct a meta-analysis. Among 219 analyzed patients, 106 (49.4%) had positive bacteremia. More frequent bacteria were S. viridans, A. actinomycetemcomitans P. gingivalis, M. micros and species Streptococcus and Actinomyces, although identification methods of microbiologic assays were different among studies. Clinical Implications Although half of the patients presented positive bacteremia after periodontal procedures, accurate results regarding the magnitude, duration and nature of bacteremia could not be confidentially assessed. PMID:24870125

  10. Thermal-Hydraulic System Codes in Nulcear Reactor Safety and Qualification Procedures

    Directory of Open Access Journals (Sweden)

    Alessandro Petruzzi

    2008-01-01

    Full Text Available In the last four decades, large efforts have been undertaken to provide reliable thermal-hydraulic system codes for the analyses of transients and accidents in nuclear power plants. Whereas the first system codes, developed at the beginning of the 1970s, utilized the homogenous equilibrium model with three balance equations to describe the two-phase flow, nowadays the more advanced system codes are based on the so-called “two-fluid model” with separation of the water and vapor phases, resulting in systems with at least six balance equations. The wide experimental campaign, constituted by the integral and separate effect tests, conducted under the umbrella of the OECD/CSNI was at the basis of the development and validation of the thermal-hydraulic system codes by which they have reached the present high degree of maturity. However, notwithstanding the huge amounts of financial and human resources invested, the results predicted by the code are still affected by errors whose origins can be attributed to several reasons as model deficiencies, approximations in the numerical solution, nodalization effects, and imperfect knowledge of boundary and initial conditions. In this context, the existence of qualified procedures for a consistent application of qualified thermal-hydraulic system code is necessary and implies the drawing up of specific criteria through which the code-user, the nodalization, and finally the transient results are qualified.

  11. Program Self-Review Procedures. Ohio Program Review for Improvement, Development, and Expansion in Vocational Education.

    Science.gov (United States)

    Ohio State Dept. of Education, Columbus. Div. of Vocational Education.

    The Ohio Program Review for Improvement, Development, and Expansion (PRIDE) in Vocational Education is a comprehensive program review system designed to define, secure, and provide useful information relative to selected vocational education objectives. This document was designed to assist the local vocational education personnel in planning and…

  12. A systematic review of music-based interventions for procedural support.

    Science.gov (United States)

    Yinger, Olivia Swedberg; Gooding, Lori F

    2015-01-01

    Individuals undergoing medical procedures frequently experience pain and anxiety. Music-based interventions have the potential to help alleviate these symptoms. This review investigated the effects of music-based interventions (music therapy and music medicine) on pain and anxiety in children and adults undergoing medical procedures. This systematic review examined randomized controlled trial music intervention studies to manage patient-reported pain and/or anxiety during medical procedures. All studies were published in English and peer-reviewed journals. Quality and risk of bias were assessed using criteria from the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR-NPT). Fifty studies met inclusion criteria, the majority of which (84%) had a high risk of bias. It was not possible to perform a meta-analysis because studies varied greatly in terms of medical procedure and intervention type. Results varied across studies, with approximately half (48%) indicating less anxiety for music intervention participants; fewer studies (36%) reported less pain for music intervention participants. There is a need to clearly define and differentiate between music therapy and music medicine interventions in procedural support research. Further research is necessary to determine which patients would benefit most from music interventions during medical procedures, and which interventions are most beneficial. To improve research quality and reduce risk of bias, when designing studies investigators need to carefully consider factors related to design, including randomization, treatment allocation concealment, blinding outcome assessors, and intention-to-treat analysis. In addition, more detailed intervention reporting is needed when publishing results. © the American Music Therapy Association 2015. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  13. What is a Bristow-Latarjet procedure? A review of the described operative techniques and outcomes.

    Science.gov (United States)

    Cowling, P D; Akhtar, M A; Liow, R Y L

    2016-09-01

    A variety of operative techniques have been described as under the term 'Bristow-Latarjet' procedure. This review aims to define the original procedure, and compare the variation in techniques described in the literature, assessing any effect on clinical outcomes. A systematic review of 24 studies was performed to compare specific steps of the technique (coracoid osteotomy site, subscapularis approach, orientation and position of coracoid graft fixation and fixation method, additional labral and capsular repair) and detect any effect this variability had on outcomes. Overall recurrence rate was 5.36% (2.94% to 43%). Half of the studies performed the procedure for recurrent shoulder instability, with only five studies documenting glenoid bone loss as an indication: 12 studies used the procedure as the primary surgical intervention for recurrent instability. No change in outcome was noted when examining variation in the coracoid osteotomy site, the fixation site on the scapular neck, the fixation method or whether a capsular repair was also performed. Performing a horizontal split in subscapularis may preserve external rotation compared with performing a tenotomy. This is the first review to examine various operative techniques of the Bristow-Latarjet procedure, and their effect on outcome. We found that other than the approach through subscapularis, outcome was independent of the surgical technique, and depended more on patient selection. We would commend future publications on this procedure to provide a detailed description of the surgical technique, and as a minimum present rates of recurrence as an outcome measure. Cite this article: Bone Joint J 2016;98-B:1208-14. ©2016 The British Editorial Society of Bone & Joint Surgery.

  14. A Review of Antiviral and Antifungal Use and Safety during Pregnancy.

    Science.gov (United States)

    Cottreau, Jessica M; Barr, Viktorija O

    2016-06-01

    Antiviral and antifungal use in pregnancy presents challenges because of the paucity of clinical and safety data for many agents in these classes. If untreated, viral and fungal infections can have deleterious effects on both maternal and fetal health. Understanding the use and risks of these medications in pregnancy is vital to provide appropriate care. This article reviews the current literature for the use of antiviral and antifungals, the pharmacokinetics of these agents, and their safety in pregnancy. © 2016 Pharmacotherapy Publications, Inc.

  15. Review and Analysis of Development of "Safety by Design" Requirements

    Energy Technology Data Exchange (ETDEWEB)

    Vance, Scott A.; Hockert, John

    2009-10-20

    This report, the deliverable for Task 4 of the NA-243 Safeguards by Design Work Plan for Fiscal Year 2009, develops the lessons to be learned for the institutionalization of Safeguards By Design (SBD) from the Department of Energy (DOE) experience developing and implementing DOE-STD-1189, Integration of Safety into the Design Process. This experience was selected for study because of the similarity of the challenges of integrating safety and safeguards into the design process. Development of DOE-STD-1189 began in January 2006 and the standard was issued for implementation in March 2008. The process was much more time consuming than originally anticipated and might not have come to fruition had senior DOE management been less committed to its success. Potentially valuable lessons can be learned from both the content and presentation of the integration approach in DOE-STD-1189 and from the DOE experience in developing and implementing DOE-STD-1189. These lessons are important because the instutionalization of SBD does not yet appear to have the level of senior management commitment afforded development and implementation of DOE-STD-1189.

  16. Review of the Safety and Efficacy of Moringa oleifera.

    Science.gov (United States)

    Stohs, Sidney J; Hartman, Michael J

    2015-06-01

    Moringa oleifera leaves, seeds, bark, roots, sap, and flowers are widely used in traditional medicine, and the leaves and immature seed pods are used as food products in human nutrition. Leaf extracts exhibit the greatest antioxidant activity, and various safety studies in animals involving aqueous leaf extracts indicate a high degree of safety. No adverse effects were reported in association with human studies. Five human studies using powdered whole leaf preparations of M. oleifera have been published, which have demonstrated anti-hyperglycemic (antidiabetic) and anti-dyslipidemic activities. These activities have been confirmed using extracts as well as leaf powders in animal studies. A rapidly growing number of published studies have shown that aqueous, hydroalcohol, or alcohol extracts of M. oleifera leaves possess a wide range of additional biological activities including antioxidant, tissue protective (liver, kidneys, heart, testes, and lungs), analgesic, antiulcer, antihypertensive, radioprotective, and immunomodulatory actions. A wide variety of polyphenols and phenolic acids as well as flavonoids, glucosinolates, and possibly alkaloids is believed to be responsible for the observed effects. Standardization of products is an issue. However, the results of published studies to date involving M. oleifera are very promising. Additional human studies using standardized extracts are highly desirable. © 2015 The Authors Phytotherapy Research Published by John Wiley & Sons Ltd.

  17. Interim radiological safety standards and evaluation procedures for subseabed high-level waste disposal

    Energy Technology Data Exchange (ETDEWEB)

    Klett, R.D.

    1997-06-01

    The Seabed Disposal Project (SDP) was evaluating the technical feasibility of high-level nuclear waste disposal in deep ocean sediments. Working standards were needed for risk assessments, evaluation of alternative designs, sensitivity studies, and conceptual design guidelines. This report completes a three part program to develop radiological standards for the feasibility phase of the SDP. The characteristics of subseabed disposal and how they affect the selection of standards are discussed. General radiological protection standards are reviewed, along with some new methods, and a systematic approach to developing standards is presented. The selected interim radiological standards for the SDP and the reasons for their selection are given. These standards have no legal or regulatory status and will be replaced or modified by regulatory agencies if subseabed disposal is implemented. 56 refs., 29 figs., 15 tabs.

  18. [Awareness and respect of procedures for hand hygiene: review of the literature].

    Science.gov (United States)

    Sansoni, Julita; Sorrentino, Milena; Giammarco, Enrichetta; Mariani, Paola

    2010-01-01

    The procedures necessary to ensure hand hygiene are simple and non-expensive but are extremely important for the patient and the quality of care he receives. It is therefore fundamental that health workers are aware of these procedures and how they should be performed to reduce the risks of care-related infections. The authors selected 195 articles from a review of the abundance of published reports in international journals, which deal with the awareness and respect of guidelines regarding hand hygiene on which to base their discussion.

  19. Informed consent procedures with cognitively impaired patients: A review of ethics and best practices.

    Science.gov (United States)

    Fields, Lindy Marie; Calvert, James Douglas

    2015-08-01

    The objectives of this article are to discuss ethical issues of informed consent in cognitively impaired patients and review considerations for capacity determination. We will also discuss how to evaluate capacity, determine competence, and obtain informed consent when a patient is deemed incompetent. This review emphasizes how to carry out informed consent procedures when capacity is questionable and discusses measures supported for use when determining cognitively impaired patients' ability to consent. Information was gathered from medical and psychological codes of ethics, peer-reviewed journals, published guidelines from health-care organizations (e.g., American Medical Association), and scholarly books. Google Scholar and PsycINFO were searched for articles related to 'informed consent' and 'cognitive impairment' published in English between 1975 and 2014. Relevant sources referenced in retrieved publications were subsequently searched and reviewed. We selected 49 sources generated by our search. Sources were included in our review if they presented information related to at least one of our focus areas. These areas included: review of informed consent ethics and procedures, review of cognitive impairment evaluations, recommendations for measuring cognitive capacity, and alternative forms of informed consent. Patients' cognitive impairments can hinder the ability of patients to understand treatment options. Evaluating the capacity of patients with cognitive impairment to understand treatment options is vital for valid informed consent and should be guided by best practices. Thus, proper identification of patients with questionable capacity, capacity evaluation, and determination of competence, as well as reliance upon appropriate alternative consent procedures, are paramount. © 2015 The Authors. Psychiatry and Clinical Neurosciences © 2015 Japanese Society of Psychiatry and Neurology.

  20. Operating procedures -- Preliminary results of a Safety and Environmental Management Program (SEMP) case study sponsored by the DOE and MMS

    Energy Technology Data Exchange (ETDEWEB)

    Bresler, R.A.; Tibbetts, O.D.; Antz, G.W. Von

    1996-12-31

    One June 30, 1994, the MMS published a Federal Register notice requesting that industry voluntarily adopt API RP 75 (SEMP). Under the SEMP program, offshore producers would be responsible for identifying potential hazards in the design, construction and operation of drilling and production platforms and developing specific approaches to reduce the occurrence of accidents. Many smaller and mid-size independent producers have raised questions over the costs and methods for implementing SEMP. The DOE and MMS determined that a carefully documented case study would answer many of the producers` questions. The results of the study would be oriented specifically to small- and mid-size companies, so independent producers would be much more willing to invest the time and resources to adapt the RP 75 procedures to their own operations. As a result, the DOE and MMS have entered into a 30-month study with Taylor Energy Company (TEC) and Paragon Engineering Services (Paragon) to develop a Safety and Environmental Management Plan (SEMP). This program is intended to demonstrate how small- to mid-size companies can effectively and inexpensively develop a SEMP in accordance with API RP 75. This paper will discuss the preliminary findings associated with the Taylor Energy Company/DOE SEMP case study. Specifically, the development of operating procedures which meet the intent and spirit of SEMP without the traditional high cost typically associated with engineered operations manuals is discussed.

  1. Acucise™ endopyelotomy in a porcine model: procedure standardization and analysis of safety and immediate efficacy

    Directory of Open Access Journals (Sweden)

    Andreoni Cássio

    2004-01-01

    Full Text Available PURPOSE: The study here presented was done to test the technical reliability and immediate efficacy of the Acucise device using a standardized technique. MATERIALS AND METHODS: 56 Acucise procedures were performed in pigs by a single surgeon who used a standardized technique: insert 5F angiographic catheter bilaterally up to the midureter, perform retrograde pyelogram, Amplatz super-stiff guidewire is advanced up to the level of the renal pelvis, angiographic catheters are removed, Acucise catheter balloon is advanced to the ureteropelvic junction (UPJ level, the super-stiff guide-wire is removed and the contrast medium in the renal pelvis is aspirated and replaced with distilled water, activate Acucise at 75 watts of pure cutting current, keep the balloon fully inflated for 10 minutes, perform retrograde ureteropyelogram to document extravasation, remove Acucise catheter and pass an ureteral stent and remove guide-wire. RESULTS: In no case did the Acucise device present malfunction. The electrocautery activation time was 2.2 seconds (ranging from 2 to 4 seconds. The extravasation of contrast medium, visible by fluoroscopy, occurred in 53 of the 56 cases (94.6%. In no case there was any evidence of intraoperative hemorrhage. CONCLUSIONS: This study revealed that performing Acucise endopyelotomy routinely in a standardized manner could largely preclude intraoperative device malfunction and eliminate complications while achieving a successful incision in the UPJ. With the guidelines that were used in this study, we believe that Acucise endopyelotomy can be completed successfully and safely in the majority of selected patients with UPJ obstruction.

  2. Panel Resource Management (PRM) Implementation and Effects within Safety Review Panel Settings and Dynamics

    Science.gov (United States)

    Taylor, Robert W.; Nash, Sally K.

    2007-01-01

    While technical training and advanced degree's assure proficiency at specific tasks within engineering disciplines, they fail to address the potential for communication breakdown and decision making errors familiar to multicultural environments where language barriers, intimidating personalities and interdisciplinary misconceptions exist. In an effort to minimize these pitfalls to effective panel review, NASA's lead safety engineers to the ISS Safety Review Panel (SRP), and Payload Safety Review Panel (PSRP) initiated training with their engineers, in conjunction with the panel chairs, and began a Panel Resource Management (PRM) program. The intent of this program focuses on the ability to reduce the barriers inhibiting effective participation from all panel attendees by bolstering participants confidence levels through increased communication skills, situational awareness, debriefing, and a better technical understanding of requirements and systems.

  3. Does classroom-based Crew Resource Management training improve patient safety culture? A systematic review.

    Science.gov (United States)

    Verbeek-van Noord, Inge; de Bruijne, Martine C; Zwijnenberg, Nicolien C; Jansma, Elise P; van Dyck, Cathy; Wagner, Cordula

    2014-01-01

    To evaluate the evidence of the effectiveness of classroom-based Crew Resource Management training on safety culture by a systematic review of literature. Studies were identified in PubMed, Cochrane Library, PsycINFO, and Educational Resources Information Center up to 19 December 2012. The Methods Guide for Comparative Effectiveness Reviews was used to assess the risk of bias in the individual studies. In total, 22 manuscripts were included for review. Training settings, study designs, and evaluation methods varied widely. Most studies reporting only a selection of culture dimensions found mainly positive results, whereas studies reporting all safety culture dimensions of the particular survey found mixed results. On average, studies were at moderate risk of bias. Evidence of the effectiveness of Crew Resource Management training in health care on safety culture is scarce and the validity of most studies is limited. The results underline the necessity of more valid study designs, preferably using triangulation methods.

  4. Idaho National Laboratory Integrated Safety Management System 2011 Effectiveness Review and Declaration Report

    Energy Technology Data Exchange (ETDEWEB)

    Farren Hunt

    2011-12-01

    Idaho National Laboratory (INL) performed an annual Integrated Safety Management System (ISMS) effectiveness review per 48 Code of Federal Regulations (CFR) 970.5223-1, 'Integration of Environment, Safety and Health into Work Planning and Execution.' The annual review assessed Integrated Safety Management (ISM) effectiveness, provided feedback to maintain system integrity, and helped identify target areas for focused improvements and assessments for fiscal year (FY) 2012. The information presented in this review of FY 2011 shows that the INL has performed many corrective actions and improvement activities, which are starting to show some of the desired results. These corrective actions and improvement activities will continue to help change culture that will lead to better implementation of defined programs, resulting in moving the Laboratory's performance from the categorization of 'Needs Improvement' to the desired results of 'Effective Performance.'

  5. Occupational Health and Safety in Ethiopia: A review of Situational ...

    African Journals Online (AJOL)

    kim

    gaps that may require attention in areas of OSH services, training, research, exposure assessment, and capacity building. The review study was approved at. Department level through ... machine characterizes manufacturing undertakings. About 85% of the ...... clusters in 21 regions, 1990–2010: a systematic analysis for the ...

  6. Table Egg Production and Consumers Safety: A Review | Usman ...

    African Journals Online (AJOL)

    which may accumulate in the egg and cause public health hazards. Microbial contamination of eggs in the process of production, handling and marketing has also been of a major public health concern. This paper reviews some of the ways table eggs can get contaminated and become unsafe for human consumption, ...

  7. A Review of Digital Addiction: A Call for Safety Education

    Science.gov (United States)

    Rugai, Joseph; Hamiliton-Ekeke, Joy-Telu

    2016-01-01

    In reviewing digital addiction, this paper recognized that digital technology has been useful in various spheres of life and the reach is undeniable, with an "average" user spending long hours on their phone or online daily. These hours increase as new applications are released by various technological companies. The demands of modern…

  8. The effectiveness of road safety education : a literature review.

    NARCIS (Netherlands)

    Dragutinovic, N. & Twisk, D.A.M.

    2007-01-01

    This literature review of traffic education programmes addresses the current practice in evaluation research, the effectiveness of programmes and their constituting components and the differences and similarities with other fields of education. The study leads to a number of conclusions which can be

  9. Safety and Efficacy of Catheter Direct Thrombolysis in Management of Acute Iliofemoral Deep Vein Thrombosis: A Systematic Review.

    Science.gov (United States)

    Elbasty, Ahmed; Metcalf, James

    2017-12-01

    Catheter direct thrombolysis (CDT) has been shown to be an effective treatment for deep venous thrombosis. The objective of the review is to improve safety and efficacy of the CDT by using ward based protocol, better able to predict complications and treatment outcome through monitoring of haemostatic parameters and clinical observation during thrombolysis procedure. MEDLINE, EMBASE, CENTRAL and Web of Science were searched for all articles on deep venous thrombosis, thrombolysis and correlations of clinical events (bleeding, successful thrombolysis) during thrombolysis with hemostatic parameters to March 2016. The risk of bias in included studies was assessed by Cochrane Collaboration's tool and Cochrane Risk of Bias Assessment Tool: for Non-Randomized Studies of Interventions. Twenty-four studies were included in the review and we found that improving safety and efficacy of CDT by using ward based protocol depending on eight factors; strict patient selection criteria, types of fibrinolytic drugs, mode of fibrinolytic drug injection, biochemical markers monitoring (fibrinogen, D-dimer, activated partial thromboplastin time, plasminogen activator inhibitor-1), timing of intervention, usage of intermittent pneumatic calf, ward monitoring and thrombolysis imaging assessment (intravascular ultrasound). These factors may help to improve safety and efficacy by reducing total thrombolytic drug dosage and at the same time ensure successful lysis. There is a marked lack of randomized controlled trials discussing the safety and efficacy of catheter direct thrombolysis. CDT can be performed safely and efficiently in clinical ward, providing that careful nursing, biochemical monitoring, proper selection and mode of infusion of fibrinolytic drugs, usage of Intermittent pneumatic calf and adequate thrombolysis imaging assessment are ensured.

  10. Multimorbidity and Patient Safety Incidents in Primary Care: A Systematic Review and Meta-Analysis

    Science.gov (United States)

    Panagioti, Maria; Stokes, Jonathan; Esmail, Aneez; Coventry, Peter; Cheraghi-Sohi, Sudeh; Alam, Rahul; Bower, Peter

    2015-01-01

    Background Multimorbidity is increasingly prevalent and represents a major challenge in primary care. Patients with multimorbidity are potentially more likely to experience safety incidents due to the complexity of their needs and frequency of their interactions with health services. However, rigorous syntheses of the link between patient safety incidents and multimorbidity are not available. This review examined the relationship between multimorbidity and patient safety incidents in primary care. Methods We followed our published protocol (PROSPERO registration number: CRD42014007434). Medline, Embase and CINAHL were searched up to May 2015. Study design and quality were assessed. Odds ratios (OR) and 95% confidence intervals (95% CIs) were calculated for the associations between multimorbidity and two categories of patient safety outcomes: ‘active patient safety incidents’ (such as adverse drug events and medical complications) and ‘precursors of safety incidents’ (such as prescription errors, medication non-adherence, poor quality of care and diagnostic errors). Meta-analyses using random effects models were undertaken. Results Eighty six relevant comparisons from 75 studies were included in the analysis. Meta-analysis demonstrated that physical-mental multimorbidity was associated with an increased risk for ‘active patient safety incidents’ (OR = 2.39, 95% CI = 1.40 to 3.38) and ‘precursors of safety incidents’ (OR = 1.69, 95% CI = 1.36 to 2.03). Physical multimorbidity was associated with an increased risk for active safety incidents (OR = 1.63, 95% CI = 1.45 to 1.80) but was not associated with precursors of safety incidents (OR = 1.02, 95% CI = 0.90 to 1.13). Statistical heterogeneity was high and the methodological quality of the studies was generally low. Conclusions The association between multimorbidity and patient safety is complex, and varies by type of multimorbidity and type of safety incident. Our analyses suggest that multimorbidity

  11. Acupuncture safety in patients receiving anticoagulants: a systematic review.

    Science.gov (United States)

    Mcculloch, Michael; Nachat, Arian; Schwartz, Jonathan; Casella-Gordon, Vicki; Cook, Joseph

    2015-01-01

    Theoretically, acupuncture in anticoagulated patients could increase bleeding risk. However, precise estimates of bleeding complication rates from acupuncture in anticoagulated patients have not been systematically examined. To critically evaluate evidence for safety of acupuncture in anticoagulated patients. We searched PubMed, EMBASE, the Physiotherapy Evidence Database, and Google Scholar. Of 39 potentially relevant citations, 11 met inclusion criteria: 2 randomized trials, 4 case series, and 5 case reports. Seven provided reporting quality sufficient to assess acupuncture safety in 384 anticoagulated patients (3974 treatments). Minor-moderate bleeding related to acupuncture in an anticoagulated patient occurred in one case: a large hip hematoma, managed with vitamin K reversal and warfarin discontinuation following reevaluation of its medical justification. Blood-spot bleeding, typical for any needling/injection and controlled with pressure/cotton, occurred in 51 (14.6%) of 350 treatments among a case series of 229 patients. Bleeding deemed unrelated to acupuncture during anticoagulation, and more likely resulting from inappropriately deep needling damaging tissue or from complex anticoagulation regimens, occurred in 5 patients. No bleeding was reported in 2 studies (74 anticoagulated patients): 1 case report and 1 randomized trial prospectively monitoring acupuncture-associated bleeding as an explicit end point. Altogether, 1 moderate bleeding event occurred in 3974 treatments (0.003%). Acupuncture appears to be safe in anticoagulated patients, assuming appropriate needling location and depth. The observed 0.003% complication rate is lower than the previously reported 12.3% following hip/knee replacement in a randomized trial of 27,360 anticoagulated patients, and 6% following acupuncture in a prospective study of 229,230 all-type patients. Prospective trials would help confirm our findings.

  12. Design Review Report for formal review of safety class features of exhauster system for rotary mode core sampling

    Energy Technology Data Exchange (ETDEWEB)

    JANICEK, G.P.

    2000-06-08

    Report documenting Formal Design Review conducted on portable exhausters used to support rotary mode core sampling of Hanford underground radioactive waste tanks with focus on Safety Class design features and control requirements for flammable gas environment operation and air discharge permitting compliance.

  13. Review of Overall Safety Manual for space nuclear systems. An evaluation of a nuclear safety analysis methodology for plutonium-fueled space nuclear systems

    Energy Technology Data Exchange (ETDEWEB)

    Coleman, J.; Inhaber, H.

    1984-02-01

    As part of its duties in connection with space missions involving nuclear power sources, the Office of Nuclear Safety (ONS) of the Office of Assistant Secretary for Environmental Protection, Safety, and Emergency Preparedness has been assigned the task of reviewing the Overall Safety Manual (OSM) (memo from B.J. Rock to J.R. Maher, December 1, 1982). The OSM, dated July 1981 and in four volumes, was prepared by NUS Corporation, Rockville, Maryland, for the US Department of Energy. The OSM provides many of the technical models and much of the data which are used by (1) space launch contractors in safety analysis reports and (2) the broader Interagency Nuclear Safety Review Panel (INSRP) safety evaluation reports. If fhs interaction between the OSM, contractors, and INSRP is to work effectively, the OSM must be accurate, comprehensive, understandable, and usable.

  14. 15 CFR 27.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

    Science.gov (United States)

    2010-01-01

    ... HUMAN SUBJECTS § 27.110 Expedited review procedures for certain kinds of research involving no more than... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research...

  15. 40 CFR 26.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

    Science.gov (United States)

    2010-07-01

    ... EPA § 26.110 Expedited review procedures for certain kinds of research involving no more than minimal... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 26...

  16. 34 CFR 97.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

    Science.gov (United States)

    2010-07-01

    ...) § 97.110 Expedited review procedures for certain kinds of research involving no more than minimal risk... 34 Education 1 2010-07-01 2010-07-01 false Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 97.110 Section 97...

  17. 38 CFR 16.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

    Science.gov (United States)

    2010-07-01

    ... AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.110 Expedited review procedures for certain kinds of research... 38 Pensions, Bonuses, and Veterans' Relief 1 2010-07-01 2010-07-01 false Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in...

  18. Implicit Memory in Korsakoff’s Syndrome: A Review of Procedural Learning and Priming Studies

    Science.gov (United States)

    Hayes, Scott M.; Fortier, Catherine B.; Levine, Andrea; Milberg, William P.; McGlinchey, Regina

    2013-01-01

    Korsakoff’s syndrome (KS) is characterized by dense anterograde amnesia resulting from damage to the diencephalon region, typically resulting from chronic alcohol abuse and thiamine deficiency. This review assesses the integrity of the implicit memory system in KS, focusing on studies of procedural learning and priming. KS patients are impaired on several measures of procedural memory, most likely due to impairment in cognitive functions associated with alcohol-related neural damage outside of the diencephalon. The pattern of performance on tasks of implicit priming suggests reliance on a residual, non-flexible memory operating more or less in an automatic fashion. Our review concludes that whether measures of implicit memory reveal intact or impaired performance in individuals with KS depends heavily on specific task parameters and demands, including timing between stimuli, the specific nature of the stimuli used in a task, and the integrity of supportive cognitive functions necessary for performance. PMID:22592661

  19. The foot-in-the-door compliance procedure: a multiple-process analysis and review.

    Science.gov (United States)

    Burger, J M

    1999-01-01

    Research on the social compliance procedure known as the foot-in-the-door (FITD) technique is reviewed. Several psychological processes that may be set in motion with a FITD manipulation are identified: self-perception, psychological reactance, conformity, consistency, attributions, and commitment. A review of relevant investigations and several meta-analyses support the notion that each of these processes can influence compliance behavior in the FITD situation. I argue that the combined effects of these processes can account for successful FITD demonstrations as well as studies in which the technique was ineffective or led to a decrease in compliance. The experimental conditions most likely to produce an FITD effect are identified.

  20. Anxiety and pain in children undergoing elective surgical procedures: a systematic review.

    Science.gov (United States)

    Jia Shermin, Chieng Ying; Sally, Chan Wai-Chi; Hong-Gu, He

    2012-01-01

    Anxiety and pain are two significant problems experienced by children undergoing elective surgical procedures, which may lead to suboptimal postoperative outcomes. Previous studies have shown a correlation between perioperative anxiety and pain in children. This review aimed to present the best available evidence on the correlation between perioperative anxiety and pain in children undergoing elective surgical procedures, and to determine the relationship between children's demographics, their anxiety and pain level in the perioperative period. Participants were children aged between five to 18 years old who were scheduled for an elective surgical procedure in the hospital setting.No specific intervention was of interest. So long as the primary studies examined correlation of children's anxiety and pain in the perioperative period, they were considered for inclusion.This review focused on children's preoperative level of anxiety; children's postoperative level of anxiety; children's postoperative pain intensity; and/or children's postoperative behavioural changes.This review included quantitative research studies, such as randomised-controlled trials, cohort studies, and descriptive studies which addressed the correlation between perioperative anxiety and perioperative pain in children undergoing elective surgical procedures. A three-step search strategy was utilised in this review. The following databases were searched for articles published in English from the inception date of databases to December 2010: CINAHL, PubMed, Scopus, PsycINFO, Mednar, Trip Database, ProQuest Dissertations and Theses, Scirus ETD and Web of Science. Papers selected for retrieval were assessed independently by two reviewers for methodological quality prior to inclusion in the review using standardised critical appraisal tools from Joanna Briggs Institute. There were no disagreements between the two reviewers, so the third reviewer was not required. Data were extracted using the

  1. Drug safety surveillance in China and other countries: a review and comparison.

    Science.gov (United States)

    Du, Wenmin; Guo, Jeff J; Jing, Yonghua; Li, Xing; Kelton, Christina M L

    2008-03-01

    Drug safety and postmarketing surveillance have become important public health issues in China. This study reviews the relatively new drug safety surveillance system in China and compares it with the systems in the United States and Europe. An extensive literature review was conducted in the following four areas: 1) the organizational structure of the State Food and Drug Administration (SFDA) in China; 2) the development of an adverse drug reaction (ADR) monitoring system in China; 3) regulatory issues related to drug safety in China; and 4) similarities and differences between drug safety surveillance in China and surveillance in the United States and Europe. The SFDA oversees an extensive network of drug safety "watchdogs," including the China National Center for ADR Monitoring and 32 regional centers throughout China. China's system has faced a number of recent challenges. It has had to respond quickly to the withdrawal of various high-profile drugs like Vioxx (rofecoxib) and Baycol (cerivastatin) from other markets. Together with China's Ministry of Health, the SFDA has faced several unique drug safety events. Three of those events, involving the injectable form of the heartleaf houttuyinia herb (Yu Xing Cao), Armillarisni A injections, and clindamycin glucose infusions (Xinfu), are discussed. The rapid development of drug safety surveillance in China is manifested in extensive organizational structure, development of large databases, and laws and regulations supporting drug safety. The two major laws are the China Drug Administration Law issued in February 2001 and the Regulation for the Administration of ADR Reporting and Monitoring issued in March 2004. The study also discusses and compares recent developments in drug safety surveillance in the United States and the European Union. These developments will most likely have implications for the Chinese system in the near future. While postmarketing surveillance guidelines are not yet available in China, we

  2. Trends in HFE Methods and Tools and Their Applicability to Safety Reviews

    Energy Technology Data Exchange (ETDEWEB)

    O' Hara, J.M.; Plott, C.; Milanski, J.; Ronan, A.; Scheff, S.; Laux, L.; and Bzostek, J.

    2009-09-30

    The U.S. Nuclear Regulatory Commission's (NRC) conducts human factors engineering (HFE) safety reviews of applicant submittals for new plants and for changes to existing plants. The reviews include the evaluation of the methods and tools (M&T) used by applicants as part of their HFE program. The technology used to perform HFE activities has been rapidly evolving, resulting in a whole new generation of HFE M&Ts. The objectives of this research were to identify the current trends in HFE methods and tools, determine their applicability to NRC safety reviews, and identify topics for which the NRC may need additional guidance to support the NRC's safety reviews. We conducted a survey that identified over 100 new HFE M&Ts. The M&Ts were assessed to identify general trends. Seven trends were identified: Computer Applications for Performing Traditional Analyses, Computer-Aided Design, Integration of HFE Methods and Tools, Rapid Development Engineering, Analysis of Cognitive Tasks, Use of Virtual Environments and Visualizations, and Application of Human Performance Models. We assessed each trend to determine its applicability to the NRC's review by considering (1) whether the nuclear industry is making use of M&Ts for each trend, and (2) whether M&Ts reflecting the trend can be reviewed using the current design review guidance. We concluded that M&T trends that are applicable to the commercial nuclear industry and are expected to impact safety reviews may be considered for review guidance development. Three trends fell into this category: Analysis of Cognitive Tasks, Use of Virtual Environments and Visualizations, and Application of Human Performance Models. The other trends do not need to be addressed at this time.

  3. Patient safety events in out-of-hospital paediatric airway management: a medical record review by the CSI-EMS.

    Science.gov (United States)

    Hansen, Matthew; Meckler, Garth; Lambert, William; Dickinson, Caitlin; Dickinson, Kathryn; Van Otterloo, Joshua; Guise, Jeanne-Marie

    2016-11-11

    To describe the frequency and characterise the nature of patient safety events in paediatric out-of-hospital airway management. We conducted a retrospective cross-sectional medical record review of all 'lights and sirens' emergency medicine services transports from 2008 to 2011 in patients <18 years of age in the Portland Oregon metropolitan area. A chart review tool (see online supplementary appendix) was adapted from landmark patient safety studies and revised after pilot testing. Expert panels of physicians and paramedics performed blinded reviews of each chart, identified safety events and described their nature. The primary outcomes were presence and severity of patient safety events related to airway management including oxygen administration, bag-valve-mask ventilation (BVM), airway adjuncts and endotracheal intubation (ETI).DC1SM110.1136/bmjopen-2016-012259.supp1supplementary appendix RESULTS: From the 11 328 paediatric transports during the study period, there were 497 'lights and sirens' (code 3) transports (4.4%). 7 transports were excluded due to missing data. Of the 490 transports included in the analysis, 329 had a total of 338 airway management procedures (some had more than 1 procedure): 61.6% were treated with oxygen, 15.3% with BVM, 8.6% with ETI and 2% with airway adjuncts. The frequency of errors was: 21% (71/338) related to oxygen use, 9.8% (33/338) related to BVM, 9.5% (32/338) related to intubation and 0.9% (3/338) related to airway adjunct use. 58% of intubations required 3 or more attempts or failed altogether. Cardiac arrest was associated with higher odds of a severe error. Errors in paediatric out-of-hospital airway management are common, especially in the context of intubations and during cardiac arrest. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  4. A Review of CAM for Procedural Pain in Infancy: Part II. Other Interventions

    Directory of Open Access Journals (Sweden)

    Jennie C. I. Tsao

    2008-01-01

    Full Text Available This article is the second in a two-part series reviewing the empirical evidence for complementary and alternative medicine (CAM approaches for the management of pain related to medical procedures in infants up to 6 weeks of age. Part I of this series investigated the effects of sucrose with or without non-nutritive sucking (NNS. The present article examines other CAM interventions for procedural pain including music-based interventions, olfactory stimulation, kangaroo care and swaddling. Computerized databases were searched for relevant studies including prior reviews and primary trials. Preliminary support was revealed for the analgesic effects of the CAM modalities reviewed. However, the overall quality of the evidence for these approaches remains relatively weak. Additional well-designed trials incorporating rigorous methodology are required. Such investigations will assist in the development of evidence-based guidelines on the use of CAM interventions either alone or in concert with conventional approaches to provide safe, reliable analgesia for infant procedural pain.

  5. Improving Safety on the International Space Station: Transitioning to Electronic Emergency Procedure Books on the International Space Station

    Science.gov (United States)

    Carter-Journet, Katrina; Clahoun, Jessica; Morrow, Jason; Duncan, Gary

    2012-01-01

    The National Aeronautics and Space Administration (NASA) originally designed the International Space Station (ISS) to operate until 2015, but have extended operations until at least 2020. As part of this very dynamic Program, there is an effort underway to simplify the certification of Commercial ]of ]the ]Shelf (COTS) hardware. This change in paradigm allows the ISS Program to take advantage of technologically savvy and commercially available hardware, such as the iPad. The iPad, a line of tablet computers designed and marketed by Apple Inc., was chosen to support this endeavor. The iPad is functional, portable, and could be easily accessed in an emergency situation. The iPad Electronic Flight Bag (EFB), currently approved for use in flight by the Federal Aviation Administration (FAA), is a fraction of the cost of a traditional Class 2 EFB. In addition, the iPad fs ability to use electronic aeronautical data in lieu of paper in route charts and approach plates can cut the annual cost of paper data in half for commercial airlines. ISS may be able to benefit from this type of trade since one of the most important factors considered is information management. Emergency procedures onboard the ISS are currently available to the crew in paper form. Updates to the emergency books can either be launched on an upcoming visiting vehicle such as a Russian Soyuz flight or printed using the onboard ISS printer. In both cases, it is costly to update hardcopy procedures. A new operations concept was proposed to allow for the use of a tablet system that would provide a flexible platform to support space station crew operations. The purpose of the system would be to provide the crew the ability to view and maintain operational data, such as emergency procedures while also allowing Mission Control Houston to update the procedures. The ISS Program is currently evaluating the safety risks associated with the use of iPads versus paper. Paper products can contribute to the flammability

  6. Use and safety of azithromycin in neonates: a systematic review.

    Science.gov (United States)

    Smith, Coral; Egunsola, Oluwaseun; Choonara, Imti; Kotecha, Sailesh; Jacqz-Aigrain, Evelyne; Sammons, Helen

    2015-12-09

    To identify the use and adverse drug reactions associated with azithromycin in neonates. Databases MEDLINE (1948-August 2015), EMBASE (1980-August 2015) and Pubmed (August 2015) were searched for studies on azithromycin in neonates. All studies involving neonates (azithromycin for which safety was evaluated. The primary outcome was adverse event (AE) associated with use of azithromycin. Use of azithromycin in neonates was the secondary outcome. A total of 11 articles involving 473 neonates were identified. 371 AEs were reported. Adverse events were mainly respiratory (358/1000 neonate), neurological (273/1000 neonates) and gastrointestinal (196/1000 neonates) in origin. Azithromycin significantly reduced the risk of bronchopulmonary dysplasia (BPD) in extremely premature neonates (RR=0.83, 95% CI 0.71 to 0.98, p=0.02). There was no significant difference in the incidence of elevated liver enzymes between the azithromycin and placebo group (p=0.76). There were four cases of infantile hypertrophic pyloric stenosis (IHPS). Azithromycin significantly reduces the risk of BPD in preterm neonates. The relationship between azithromycin and IHPS requires further investigation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. Safety of Levetiracetam in Paediatrics: A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Oluwaseun Egunsola

    Full Text Available To identify adverse events (AEs associated with Levetiracetam (LEV in children.Databases EMBASE (1974-February 2015 and Medline (1946-February 2015 were searched for articles in which paediatric patients (≤18 years received LEV treatment for epilepsy. All studies with reports on safety were included. Studies involving adults, mixed age population (i.e. children and adults in which the paediatric subpopulation was not sufficiently described, were excluded. A meta-analysis of the RCTs was carried out and association between the commonly reported AEs or treatment discontinuation and the type of regimen (polytherapy or monotherapy was determined using Chi2 analysis.Sixty seven articles involving 3,174 paediatric patients were identified. A total of 1,913 AEs were reported across studies. The most common AEs were behavioural problems and somnolence, which accounted for 10.9% and 8.4% of all AEs in prospective studies. 21 prospective studies involving 1120 children stated the number of children experiencing AEs. 47% of these children experienced AEs. Significantly more children experienced AEs with polytherapy (64% than monotherapy (22% (p<0.001. Levetiracetam was discontinued in 4.5% of all children on polytherapy and 0.9% on monotherapy (p<0.001, the majority were due to behavioural problems.Behavioural problems and somnolence were the most prevalent adverse events to LEV and the most common causes of treatment discontinuation. Children on polytherapy have a greater risk of adverse events than those receiving monotherapy.

  8. Surgical and procedural skills training at medical school - a national review.

    Science.gov (United States)

    Davis, Christopher R; Toll, Edward C; Bates, Anthony S; Cole, Matthew D; Smith, Frank C T

    2014-01-01

    This national study quantifies procedural and surgical skills training at medical schools in the United Kingdom (UK), a stipulated requirement of all graduates by the General Medical Council (GMC). A questionnaire recorded basic procedural and surgical skills training provided by medical schools and surgical societies in the UK. Skills were extracted from (1) GMC Tomorrows Doctors and (2) The Royal College of Surgeons Intercollegiate Basic Surgical Skills (BSS) course. Data from medical school curricula and extra-curricular student surgical societies were compared against the national GMC guidelines and BSS course content. Data were analysed using Mann-Whitney U tests. Representatives from 23 medical schools completed the survey (71.9% response). Thirty one skills extracted from the BSS course were split into 5 categories, with skills content cross referenced against GMC documentation. Training of surgical skills by medical schools was as follows: Gowning and gloving (72.8%), handling instruments (29.4%), knot tying (17.4%), suturing (24.7%), other surgical techniques (4.3%). Surgical societies provided significantly more training of knot tying (64.4%, P = 0.0013) and suturing (64.5%, P = 0.0325) than medical schools. Medical schools provide minimal basic surgical skills training, partially supplemented by extracurricular student surgical societies. Our findings suggest senior medical students do not possess simple surgical and procedural skills. Newly qualified doctors are at risk of being unable to safely perform practical procedures, contradicting GMC Guidelines. We propose a National Undergraduate Curriculum in Surgery and Surgical Skills to equip newly qualified doctors with basic procedural skills to maximise patient safety. Copyright © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  9. Patient safety culture in hospitals of Iran: a systematic review and meta-analysis.

    Science.gov (United States)

    Azami-Aghdash, Saber; Ebadifard Azar, Farbod; Rezapour, Aziz; Azami, Akbar; Rasi, Vahid; Klvany, Khalil

    2015-01-01

    Nowadays, for quality improvement, measuring patient safety culture (PSC) in healthcare organizations is being increasingly used. The aim of this study was to clarify PSC status in Iranian hospitals using a meta-analysis method. Six databases were searched: PubMed, Scopus, Google Scholar, Cochrane Library, Magiran, SID and IranMedex using the search terms including patient safety, patient safety culture, patient safety climate and combined with hospital (such as "hospital survey on patient safety culture"), measurement, assessment, survey and Iran. A total of 11 articles which conducted using Hospital Survey on Patient Safety Culture (HSOPSC) questionnaire initially were reviewed. To estimate overall PSC status and perform the meta-analyses, Comprehensive Meta-Analysis (CMA) software v. 2 was employed. The overall PSC score based on the random model was 50.1%. "Teamwork within hospital units" dimension received the highest score of PSC (67.4%) and "Non-punitive response to error" the lowest score (32.4%). About 41% of participants in reviewed articles evaluate their hospitals' performance in PSC as 'excellent/very good'. Approximately %52.7 of participants did not report any adverse event in the past 12 months. The results of this study show that Iranian hospitals' performances in PSC were poor. Among the 12 dimensions of HSOPSC questionnaire, the "Non-punitive response to error" achieved the lowest score and could be a priority for future interventions. In this regard, hospitals staff should be encouraged to report adverse event without fear of punitive action.

  10. Review of Test Procedure for Determining HSPFs of Residential Variable-Speed Heat Pumps

    Energy Technology Data Exchange (ETDEWEB)

    Rice, C. Keith [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Munk, Jeffrey D. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Shrestha, Som S. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2015-08-01

    This report reviews the suitability of the existing Heating Seasonal Performance Factor (HSPF) ratings and testing requirements for the current generation of variable-speed (VS) air-source heat pumps. Recent field test results indicate larger discrepancies between rated HSPF and field-observed HSPF for VS models than for single-speed models in the same houses. These findings suggest that the heating season test and ratings procedure should be revisited for VS heat pumps. The ratings and testing procedures are described in ANSI/AHRI 210/240 (2008) for single-speed, two-capacity, and variable-speed units. Analysis of manufacturer and independent test performance data on VS units reveals why the current VS testing/ratings procedure results in overly optimistic HSPF ratings for some VS units relative to other types of heat pumps. This is due to a combination of extrapolation of low speed test data beyond the originally anticipated ambient temperature operating range and the constraints of unit controls, which prevent low speed operation over the range of ambient temperatures assumed in the procedure for low speed. As a result, the HSPFs of such units are being overpredicted relative to those for single- and two-capacity designs. This overprediction has been found to be significantly reduced by use in the HSPF ratings procedure of an alternative higher-load heating load line, described in a companion report (Rice et al., 2015).

  11. Report: EPA’s Review of Applications for a Water Research Grant Did Not Follow All Review Procedures and Lacked Transparency

    Science.gov (United States)

    Report #12-P-0864, September 25, 2012. NCER did not follow all applicable policies and procedures in reviewing applications submitted under RFA EPA-G2009-STAR-F1, and lacked procedures for a key aspect of its STAR grant application peer review process.

  12. The effect of economic downturn on the volume of surgical procedures: A systematic review.

    Science.gov (United States)

    Fujihara, Nasa; Lark, Meghan E; Fujihara, Yuki; Chung, Kevin C

    2017-08-01

    Economic downturn can have a wide range of effects on medicine at both individual and national levels. We aim to describe these effects in relation to surgical volume to guide future planning for physician specialization, patient expectations in the face of economic crises, or estimating healthcare expenditure. We hypothesized that because of high out-of-pocket costs, cosmetic procedure volumes would be most affected by economic decline. A systematic review was conducted using MEDLINE, Embase, and ABI/INFORMS. The main search terms were "economic recession" and "surgical procedures, operative". Studies were included if surgical volumes were measured and economic indicators were used as predictors of economic conditions. Twelve studies were included, and the most common subject was cosmetic (n = 5), followed by orthopedic (n = 2) and cardiac surgeries (n = 2). The majority of studies found that in periods of economic downturn, surgical volume decreased. Among the eight studies using Pearson's correlation analysis, there were no significant differences between cosmetic procedures and other elective procedures, indicating that cosmetic procedures may display trends similar to those of non-cosmetic elective procedures in periods of economic downturn. Surgical volume generally decreased when economic indicators declined, observed for both elective and non-elective surgery fields. However, a few specific procedure volumes such as vasectomy and caesarean section for male babies increased during the economic downturn. Knowledge of these trends can be useful for future surgical planning and distribution of healthcare resources. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  13. A Systematic Review of the Use of Social Media for Food Safety Risk Communication.

    Science.gov (United States)

    Overbey, Katie N; Jaykus, Lee-Ann; Chapman, Benjamin J

    2017-09-01

    This article covers the current published literature related to the use of social media in food safety and infectious disease communication. The aim was to analyze literature recommendations and draw conclusions about how best to utilize social media for food safety risk communication going forward. A systematic literature review was conducted, and 24 articles were included for analysis. The inclusion criteria were (i) original peer-reviewed articles and (ii) primary focus on communication through social media about food safety and/or infectious diseases. Studies were coded for themes about social media applications, benefits, limitations, and best practices. Trust and personal beliefs were important drivers of social media use. The wide reach, immediacy, and information gathering capacities of social media were frequently cited benefits. Suggestions for social media best practices were inconsistent among studies, and study designs were highly variable. More evidence-based suggestions are needed to better establish guidelines for social media use in food safety and infectious disease risk communication. The information gleaned from this review can be used to create effective messages for shaping food safety behaviors.

  14. 78 FR 40443 - Submission for OMB Review; Comment Request-Virginia Graeme Baker Pool and Spa Safety Act...

    Science.gov (United States)

    2013-07-05

    ... COMMISSION Submission for OMB Review; Comment Request--Virginia Graeme Baker Pool and Spa Safety Act... verify whether pools and spas are in compliance with the Virginia Graeme Baker Pool and Spa Safety Act... inspections per year under the Virginia Graeme Baker Pool and Spa Safety Act. Investigators typically...

  15. 77 FR 76005 - Submission for OMB Review; Comment Request-Safety Standard for Walk-Behind Power Lawn Mowers

    Science.gov (United States)

    2012-12-26

    ... COMMISSION Submission for OMB Review; Comment Request--Safety Standard for Walk-Behind Power Lawn Mowers... approval of a collection of information associated with the Commission's safety standard for walk- behind... required in the Safety Standard for Walk-Behind Power Lawn Mowers (16 CFR Part 1205). Three comments were...

  16. Contraceptive safety among women with cystic fibrosis: a systematic review.

    Science.gov (United States)

    Whiteman, Maura K; Oduyebo, Titilope; Zapata, Lauren B; Walker, Seth; Curtis, Kathryn M

    2016-12-01

    With dramatic improvements in life expectancy for cystic fibrosis (CF) patients, contraception for women with CF has become an important issue. There are theoretical concerns that hormonal contraceptive use among women with CF may impact disease severity or risk for other adverse health outcomes, including thrombosis and poor bone health, as well as concerns that malabsorption or altered drug metabolism might impact contraceptive effectiveness. To evaluate evidence on the safety and effectiveness of contraceptive methods among women with CF. We searched the PubMed database for all articles published from database inception through October 2015. We included studies that examined measures of disease severity, other health outcomes or indicators of contraceptive effectiveness among women with CF initiating or continuing a contraceptive method. Seven studies met our inclusion criteria. Three observational studies of fair to poor quality suggest that use of oral contraceptives (OCs) does not negatively impact CF disease severity, defined as changes in pulmonary function, number of exacerbations or need for intravenous antibiotics. Three small studies of poor quality reported on contraceptive failure among women with CF using combined hormonal contraceptives (combined OCs, patch or ring). One pregnancy was reported in a patch user out of 43 hormonal contraceptive users across all studies. One pharmacokinetic study reported that women with CF achieve steroid hormone plasma concentrations similar to healthy women after ingestion of combined OCs. Limited evidence suggests that hormonal contraceptive use does not negatively impact disease severity among women with CF and that hormonal contraceptive effectiveness is not impaired by CF. Studies were limited by small sample sizes and short duration of follow-up. No studies examined the effect of hormonal contraception on thrombosis or bone health among women with CF. Published by Elsevier Inc.

  17. A comparative review of patient safety initiatives for national health information technology

    DEFF Research Database (Denmark)

    Magrabi, Farah; Aarts, Jos; Nøhr, Christian

    2013-01-01

    OBJECTIVE: To collect and critically review patient safety initiatives for health information technology (HIT). METHOD: Publicly promulgated set of advisories, recommendations, guidelines, or standards potentially addressing safe system design, build, implementation or use were identified...... were aimed at certification in the USA, Canada and Australia. Safety is addressed alongside interoperability in the Australian certification programme but it is not explicitly addressed in the US and Canadian programmes, though conformance with specific functionality, interoperability, security...... and privacy requirements may lead to safer systems. England appears to have the most comprehensive safety management programme for unregulated software, incorporating safety assurance at a local healthcare organisation level based on standards for risk management and user interface design, with national...

  18. The effect of neighborhood on crime and safety: a review of the evidence.

    Science.gov (United States)

    Brisson, Daniel; Roll, Susan

    2012-01-01

    There is a growing, multidisciplinary body of evidence on the effects that neighborhoods have on family outcomes. This evidence is important for social workers as we work with clients and communities from a person-in-environment perspective. In this article the authors present findings from a systematic, integrative review of neighborhood effects specifically for crime and safety. Thirty-seven research studies using random samples from urban, U.S. areas between 2002 and 2008 are reviewed. Findings suggest socio-demographic characteristics of neighborhoods and neighborhood processes are both predictive of crime and safety. Further, some neighborhood conditions may affect crime and safety in unexpected ways. Implications for social work practice, neighborhood interventions, and evidence-based practice are discussed.

  19. Estradiol gel : review of the pharmacology, pharmacokinetics, efficacy, and safety in menopausal women

    NARCIS (Netherlands)

    Naunton, M.; Al Hadithy, A.F.Y.; Brouwers, J.R.B.J.; Archer, D.F.

    2006-01-01

    Objective: To review the pharmacology, pharmacokinetics, safety, and efficacy of a gel containing estradiol that is applied to the skin. Design: MEDLINE and EMBASE searches were conducted from 1966 to March 2005. Additional references were identified from bibliographies from selected studies in

  20. Efficacy and safety of medical cannabinoids in older subjects: A systematic review

    NARCIS (Netherlands)

    Elsen, G.A.H. van den; Ahmed, A.I.A.; Lammers, M.; Kramers, C.; Verkes, R.J.; Marck, M.A. van der; Olde Rikkert, M.G.M.

    2014-01-01

    This systematic review aims to integrate the evidence on indications, efficacy, safety and pharmacokinetics of medical cannabinoids in older subjects. The literature search was conducted using PubMed, EMBASE, CINAHL and Cochrane Library. We selected controlled trials including solely older subjects

  1. A Review and Comparative Analysis of Security Risks and Safety Measures of Mobile Health Apps

    National Research Council Canada - National Science Library

    Karen Scott; Deborah Richards; Rajindra Adhikari

    2015-01-01

    ...’ personal and health information. Based on a review of the literature, this paper identifies a set of risk and safety features for evaluating mHealth apps and uses those features to conduct a comparative analysis of the 20 most popular mHealth apps...

  2. Learning from aviation to improve safety in the operating room - a systematic literature review

    NARCIS (Netherlands)

    L.S.G.L. Wauben; J.F. Lange (Johan); R.H.M. Goossens (Richard)

    2012-01-01

    textabstractLessons learned from other high-risk industries could improve patient safety in the operating room (OR). This review describes similarities and differences between high-risk industries and describes current methods and solutions within a system approach to reduce errors in the OR. PubMed

  3. Safety of oscillating-rotating powered brushes compared to manual toothbrushes: a systematic review

    NARCIS (Netherlands)

    van der Weijden, F.A.; Campbell, S.L.; Dörfer, C.E.; Gonzalez-Cabezas, C.; Slot, D.E.

    2011-01-01

    Background: Oscillating-rotating power toothbrushes have been proven clinically efficacious. To our knowledge, a comprehensive review of all clinical and laboratory investigations solely comparing the safety of these toothbrushes to the standard of care (i.e., manual toothbrushes) has not been

  4. Systematic Review of Kinship Care Effects on Safety, Permanency, and Well-Being Outcomes

    Science.gov (United States)

    Winokur, Marc A.; Holtan, Amy; Batchelder, Keri E.

    2018-01-01

    Objective: Children in out-of-home placements typically display more educational, behavioral, and psychological problems than do their peers. This systematic review evaluated the effect of kinship care placement compared to foster care placement on the safety, permanency, and well-being of children removed from the home for maltreatment. Methods:…

  5. A review of case studies evaluating economic incentives to promote occupational safety and health

    NARCIS (Netherlands)

    Elsler, D.; Treutlein, D.; Rydlewska, I.; Frusteri, L.; Krüger, H.; Veerman, T.; Eeckelaert, L.; Roskams, N.; Broek, K. van den; Taylor, T.N.

    2010-01-01

    Objectives: In many European countries, external economic incentives are discussed as a policy instrument to promote occupational safety and health (OSH) in enterprises. This narrative case study review aims to support policy-makers in organizations providing such incentives by supplying information

  6. Data from Telecommunication Networks for Incident Management: An Exploratory Review on Transport Safety and Security

    NARCIS (Netherlands)

    Steenbruggen, J.G.M.; Borzacchiello, M.T.; Nijkamp, P.; Scholten, H.J.

    2013-01-01

    Problems such as traffic congestion and environmental sustainability are forcing us to review our long-term plans for transport, whose aim should be to develop and improve safety, security and effectiveness of the transportation systems. The consequences of traffic accidents are not only limited to

  7. Speaking up for patient safety by hospital-based health care professionals: a literature review.

    NARCIS (Netherlands)

    Okuyama, A.; Wagner, C.; Bijnen, B.

    2014-01-01

    Background: Speaking up is important for patient safety, but often, health care professionals hesitate to voice concerns. Understanding the influencing factors can help to improve speaking-up behaviour and team communication. This review focused on health care professionals’ speaking-up behaviour

  8. Speaking up for patient safety by hospital-based health care professionals: a literature review

    NARCIS (Netherlands)

    Okuyama, A.; Wagner, C.; Bijnen, A.B.

    2014-01-01

    Background: Speaking up is important for patient safety, but often, health care professionals hesitate to voice concerns. Understanding the influencing factors can help to improve speaking-up behaviour and team communication. This review focused on health care professionals' speaking-up behaviour

  9. Use of mobile phones while driving : effects on road safety : a literature review.

    NARCIS (Netherlands)

    Dragutinovic, N. & Twisk, D.A.M.

    2006-01-01

    The use of mobile phones while driving has become a road safety concern and has been the focus of various behavioural studies. This literature review analyses studies published in the period 1999-2005, and include simulator studies, closed-track studies and studies on the real road. Although studies

  10. Improving safety in the operating room: a systematic literature review of retained surgical sponges.

    Science.gov (United States)

    Wan, Wenshuai; Le, Thuan; Riskin, Loren; Macario, Alex

    2009-04-01

    Gossypibomas are surgical sponges that are unintentionally left inside a patient during a surgical procedure. To improve this patient safety indicator, anesthesiologists will need to work with operating room personnel. This study's goal was to systematically review the literature on retained sponges to identify body location, time to discovery, methods for detection, and risk factors. Two hundred and fifty-four gossypiboma cases (147 reports from the period 1963-2008) were identified via the National Library of Medicine's Medline and the Cochrane Library. Gossypibomas (mean patient age 49 years, range 6-92 years) were most commonly found in the abdomen (56%), pelvis (18%), and thorax (11%). Average discovery time equaled 6.9 years (SD 10.2 years) with a median (quartiles) of 2.2 years (0.3-8.4 years). The most common detection methods were computed tomography (61%), radiography (35%), and ultrasound (34%). Pain/irritation (42%), palpable mass (27%), and fever (12%) were the leading signs and symptoms, but 6% of cases were asymptomatic. Complications included adhesion (31%), abscess (24%), and fistula (20%). Risk factors were case specific (e.g. emergency) or related to the surgical environment (e.g. poor communication). Most gossypibomas occurred when the sponge count was falsely pronounced correct at the end of surgery. More is being discovered about the patterns leading to a retained sponge. Multidisciplinary approaches and new technologies may help reduce this low frequency but clinically significant event. However, given the complexity of surgical care, eliminating retained sponges may prove elusive.

  11. Saccharin. Review of safety issues. Council on Scientific Affairs.

    Science.gov (United States)

    1985-11-08

    This report reviews the experimental and epidemiologic data related to the carcinogenicity of saccharin. The results of animal studies suggest a species and organ effect. In single-generation studies in rats, mice, hamsters, and monkeys, saccharin did not induce cancer in any organ. In two-generation studies involving rats, however, there was evidence that the incidence of bladder tumors was significantly greater in saccharin-treated males of the second generation than in controls; the development of bladder tumors in rats seems to be a species- and organ-specific phenomenon for which there is currently no explanation. In humans, available evidence indicates that the use of artificial sweeteners, including saccharin, is not associated with an increased risk of bladder cancer. Until there is firm evidence of its carcinogenicity in humans, saccharin should continue to be available as a food additive, and reports of adverse health effects associated with its use should be monitored.

  12. PROCEDURAL AND SUBSTANTIVE JUDICIAL REVIEW OF THE RIGHT TO HEALTH IN BRAZIL

    Directory of Open Access Journals (Sweden)

    R. Perlingeiro

    2015-01-01

    Full Text Available This text seeks to identify the objective and subjective aspects of rights to an existential minimum in health care, based on international parameters which, because they are restricted to the internal scope of a nation, depend on a constitutional basis and on comprehensible facts, the demonstration of which should be the responsibility of the national administrative authority. Regarding the judicial review of the minimum right to healthcare, this paper points out that it is a serious mistake to try to handle public health conflicts according to the typical judicial principles governing conflicts under private law, because that distorts the public health system, with judicial orders that depart from the universal access to health care and that are often impossible to comply with. The article concludes that the judicial review of administrative authorities in matters involving the right to health necessarily requires simultaneous judicial review of the corresponding administrative procedures.

  13. Status of patient safety culture in Arab countries: a systematic review.

    Science.gov (United States)

    Elmontsri, Mustafa; Almashrafi, Ahmed; Banarsee, Ricky; Majeed, Azeem

    2017-02-24

    To explore the status of patient safety culture in Arab countries based on the findings of the Hospital Survey on Patient Safety Culture (HSPSC). Systematic review. We performed electronic searches of the MEDLINE, EMBASE, CINAHL, ProQuest and PsychINFO, Google Scholar and PubMed databases, with manual searches of bibliographies of included articles and key journals. We included studies that were conducted in the Arab countries that were focused on patient safety culture. 2 reviewers independently verified that the studies met the inclusion criteria and critically assessed the quality of the studies. 18 studies met our inclusion criteria. The review identified that non-punitive response to error is seen as a serious issue which needs to be improved. Healthcare professionals in the Arab countries tend to think that a 'culture of blame' still exists that prevents them from reporting incidents. We found an overall similarity between the reported composite score for dimension of teamwork within units in all of the reviewed studies. Teamwork within units was found to be better than teamwork across hospital units. All of the reviewed studies reported that organisational learning and continuous improvement was satisfactory as the average score of this dimension for all studies was 73.2%. Moreover, the review found that communication openness seems to be a concerning issue for healthcare professionals in the Arab countries. There is a need to promote patient safety culture as a strategy for improving the patient safety in the Arab world. Improving patient safety culture should include all stakeholders, like policymakers, healthcare providers and those responsible for medical education. This review was limited only to English language publications. The varied settings in which the HSPSC was used may have influenced the areas of strengths and weaknesses as healthcare workers' perception of safety culture may differ. Published by the BMJ Publishing Group Limited. For

  14. Human safety review of "nano" titanium dioxide and zinc oxide.

    Science.gov (United States)

    Schilling, Karsten; Bradford, Bobbie; Castelli, Dominique; Dufour, Eric; Nash, J Frank; Pape, Wolfgang; Schulte, Stefan; Tooley, Ian; van den Bosch, Jeroen; Schellauf, Florian

    2010-04-01

    Based on the current weight of evidence of all available data, the risk for humans from the use of nano-structured titanium dioxide (TiO(2)) or zinc oxide (ZnO) currently used in cosmetic preparations or sunscreens is considered negligible. There is a large body of information that when viewed in its entirety is considered as sufficient to demonstrate that these nano-structured ultraviolet (UV) filters, irrespective of various treatments (coatings) or crystalline structure, can be regarded as safe for use at concentrations up to 25% in cosmetic products to protect the skin from harmful effects of solar UV radiation. "Nano" TiO(2) and ZnO formulated in topically applied sunscreen products exist as aggregates of primary particles ranging from 30-150 nm in size. These aggregates are bonded such that the force of sunscreen product application onto the skin would have no impact on their structure or result in the release of primary particles. Multiple studies have shown that under exaggerated test conditions neither nano-structured TiO(2) nor ZnO penetrates beyond the stratum corneum of skin. Further, the distribution and persistence of these nano-structured metal oxides is the same compared to larger pigment-grade (i.e., >100 nm) particles, demonstrating equivalence in the recognition and elimination of such material from the body. Finally, the in vitro genotoxic and photogenotoxic profiles of these nano-structured metal oxides are of no consequence to human health. Whereas the most logical, straightforward conclusion based on data from internationally-recognized guideline studies and current 20+ year history of human use is that nano-structured TiO(2) and ZnO are safe, there will continue to be questions as "nano" conjures images of technology gone awry. Despite this rather sober view, the public health benefits of sunscreens containing nano TiO(2) and/or ZnO outweigh human safety concerns for these UV filters.

  15. Improving the governance of patient safety in emergency care: a systematic review of interventions.

    Science.gov (United States)

    Hesselink, Gijs; Berben, Sivera; Beune, Thimpe; Schoonhoven, Lisette

    2016-01-29

    To systematically review interventions that aim to improve the governance of patient safety within emergency care on effectiveness, reliability, validity and feasibility. A systematic review of the literature. PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Database of Systematic Reviews and PsychInfo were searched for studies published between January 1990 and July 2014. We included studies evaluating interventions relevant for higher management to oversee and manage patient safety, in prehospital emergency medical service (EMS) organisations and hospital-based emergency departments (EDs). Two reviewers independently selected candidate studies, extracted data and assessed study quality. Studies were categorised according to study quality, setting, sample, intervention characteristics and findings. Of the 18 included studies, 13 (72%) were non-experimental. Nine studies (50%) reported data on the reliability and/or validity of the intervention. Eight studies (44%) reported on the feasibility of the intervention. Only 4 studies (22%) reported statistically significant effects. The use of a simulation-based training programme and well-designed incident reporting systems led to a statistically significant improvement of safety knowledge and attitudes by ED staff and an increase of incident reports within EDs, respectively. Characteristics of the interventions included in this review (eg, anonymous incident reporting and validation of incident reports by an independent party) could provide useful input for the design of an effective tool to govern patient safety in EMS organisations and EDs. However, executives cannot rely on a robust set of evidence-based and feasible tools to govern patient safety within their emergency care organisation and in the chain of emergency care. Established strategies from other high-risk sectors need to be evaluated in emergency care settings, using an experimental design with valid outcome measures

  16. Retrospective review of Contura HDR breast cases to improve our standardized procedure

    Energy Technology Data Exchange (ETDEWEB)

    Iftimia, Ileana, E-mail: Ileana.n.iftimia@lahey.org [Lahey Clinic, Radiation Oncology Department, MA (United States); Cirino, Eileen T.; Ladd, Ron; Mower, Herbert W.; McKee, Andrea B. [Lahey Clinic, Radiation Oncology Department, MA (United States)

    2013-07-01

    To retrospectively review our first 20 Contura high dose rate breast cases to improve and refine our standardized procedure and checklists. We prepared in advance checklists for all steps, developed an in-house Excel spreadsheet for second checking the plan, and generated a procedure for efficient contouring and a set of optimization constraints to meet the dose volume histogram criteria. Templates were created in our treatment planning system for structures, isodose levels, optimization constraints, and plan report. This study reviews our first 20 high dose rate Contura breast treatment plans. We followed our standardized procedure for contouring, planning, and second checking. The established dose volume histogram criteria were successfully met for all plans. For the cases studied here, the balloon-skin and balloon-ribs distances ranged between 5 and 43 mm and 1 and 33 mm, respectively; air{sub s}eroma volume/PTV{sub E}val volume≤5.5% (allowed≤10%); asymmetry<1.2 mm (goal≤2 mm); PTV{sub E}val V90%≥97.6%; PTV{sub E}val V95%≥94.9%; skin max dose≤98%Rx; ribs max dose≤137%Rx; V150%≤29.8 cc; V200%≤7.8 cc; the total dwell time range was 225.4 to 401.9 seconds; and the second check agreement was within 3%. Based on this analysis, more appropriate ranges for the total dwell time and balloon diameter tolerance were found. Three major problems were encountered: balloon migration toward the skin for small balloon-to-skin distances, lumen obstruction, and length change for the flexible balloon. Solutions were found for these issues and our standardized procedure and checklists were updated accordingly. Based on our review of these cases, the use of checklists resulted in consistent results, indicating good coverage for the target without sacrificing the critical structures. This review helped us to refine our standardized procedure and update our checklists.

  17. Patient safety in out-of-hours primary care: a review of patient records

    Directory of Open Access Journals (Sweden)

    Wensing Michel

    2010-12-01

    Full Text Available Abstract Background Most patients receive healthcare in primary care settings, but relatively little is known about patient safety. Out-of-hours contacts are of particular importance to patient safety. Our aim was to examine the incidence, types, causes, and consequences of patient safety incidents at general practice cooperatives for out-of-hours primary care and to examine which factors were associated with the occurrence of patient safety incidents. Methods A retrospective study of 1,145 medical records concerning patient contacts with four general practice cooperatives. Reviewers identified records with evidence of a potential patient safety incident; a physician panel determined whether a patient safety incident had indeed occurred. In addition, the panel determined the type, causes, and consequences of the incidents. Factors associated with incidents were examined in a random coefficient logistic regression analysis. Results In 1,145 patient records, 27 patient safety incidents were identified, an incident rate of 2.4% (95% CI: 1.5% to 3.2%. The most frequent incident type was treatment (56%. All incidents had at least partly been caused by failures in clinical reasoning. The majority of incidents did not result in patient harm (70%. Eight incidents had consequences for the patient, such as additional interventions or hospitalisation. The panel assessed that most incidents were unlikely to result in patient harm in the long term (89%. Logistic regression analysis showed that age was significantly related to incident occurrence: the likelihood of an incident increased with 1.03 for each year increase in age (95% CI: 1.01 to 1.04. Conclusion Patient safety incidents occur in out-of-hours primary care, but most do not result in harm to patients. As clinical reasoning played an important part in these incidents, a better understanding of clinical reasoning and guideline adherence at GP cooperatives could contribute to patient safety.

  18. Determinants of safety outcomes and performance: A systematic literature review of research in four high-risk industries.

    Science.gov (United States)

    Cornelissen, Pieter A; Van Hoof, Joris J; De Jong, Menno D T

    2017-09-01

    In spite of increasing governmental and organizational efforts, organizations still struggle to improve the safety of their employees as evidenced by the yearly 2.3 million work-related deaths worldwide. Occupational safety research is scattered and inaccessible, especially for practitioners. Through systematically reviewing the safety literature, this study aims to provide a comprehensive overview of behavioral and circumstantial factors that endanger or support employee safety. A broad search on occupational safety literature using four online bibliographical databases yielded 27.527 articles. Through a systematic reviewing process 176 online articles were identified that met the inclusion criteria (e.g., original peer-reviewed research; conducted in selected high-risk industries; published between 1980-2016). Variables and the nature of their interrelationships (i.e., positive, negative, or nonsignificant) were extracted, and then grouped and classified through a process of bottom-up coding. The results indicate that safety outcomes and performance prevail as dependent research areas, dependent on variables related to management & colleagues, work(place) characteristics & circumstances, employee demographics, climate & culture, and external factors. Consensus was found for five variables related to safety outcomes and seven variables related to performance, while there is debate about 31 other relationships. Last, 21 variables related to safety outcomes and performance appear understudied. The majority of safety research has focused on addressing negative safety outcomes and performance through variables related to others within the organization, the work(place) itself, employee demographics, and-to a lesser extent-climate & culture and external factors. This systematic literature review provides both scientists and safety practitioners an overview of the (under)studied behavioral and circumstantial factors related to occupational safety behavior. Scientists

  19. Morbidity in combined-procedure associating abdominoplasty and breast surgery: A systematic review.

    Science.gov (United States)

    Michot, A; Alet, J-M; Pélissier, P; Grolleau-Raoux, J-L; Bodin, F; Chaput, B

    2016-02-01

    Combined aesthetic procedures are an increasing procedure and demands of the patients. The authors have assembled concrete arguments detailing the risks of combined-surgery associating abdominoplasty and mammoplasty relative to abdominoplasty alone. The purpose of this study was to compare abdominoplasty alone versus abdominoplasty combined with breast surgery in terms of short-term complications, in support of surgical choices. Through application of the PRISMA criteria, we have realized a systematic review of the literature from 1969 to April 2015 in English and French languages by searching in MEDLINE®, PubMed central, Embase and Cochrane Library databases. The levels of evidence for each article were evaluated. Statistical analysis of the results was carried out through association parameters including statistical tests and Odds ratios were calculated for each complication when data was available. We included 32 observational studies that met the inclusion criteria but only four with usable data. We highlighted a combined Odds ratio of respectively 5.35 and 14.71 for major complications in these studies for combined-surgery compared with abdominoplasty alone. The results of this systematic review appears in favor of an increase in major complications related to abdominoplasty combined with breast surgery compared to abdominoplasty alone but the level of evidence of included studies is low or moderate. Prospective cohort comparative studies are necessary to provide strong evidence. However, we recommend to avoid this procedure in massive weight loss patients or patients with thromboembolism history. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  20. Systematic review of "filling" procedures for lip augmentation regarding types of material, outcomes and complications.

    Science.gov (United States)

    San Miguel Moragas, Joan; Reddy, Rajgopal R; Hernández Alfaro, Federico; Mommaerts, Maurice Y

    2015-07-01

    The ideal lip augmentation technique provides the longest period of efficacy, lowest complication rate, and best aesthetic results. A myriad of techniques have been described for lip augmentation, but the optimal approach has not yet been established. This systematic review with meta-regression will focus on the various filling procedures for lip augmentation (FPLA), with the goal of determining the optimal approach. A systematic search for all English, French, Spanish, German, Italian, Portuguese and Dutch language studies involving FPLA was performed using these databases: Elsevier Science Direct, PubMed, Highwire Press, Springer Standard Collection, SAGE, DOAJ, Sweetswise, Free E-Journals, Ovid Lippincott Williams & Wilkins, Willey Online Library Journals, and Cochrane Plus. The reference section of every study selected through this database search was subsequently examined to identify additional relevant studies. The database search yielded 29 studies. Nine more studies were retrieved from the reference sections of these 29 studies. The level of evidence ratings of these 38 studies were as follows: level Ib, four studies; level IIb, four studies; level IIIb, one study; and level IV, 29 studies. Ten studies were prospective. This systematic review sought to highlight all the quality data currently available regarding FPLA. Because of the considerable diversity of procedures, no definitive comparisons or conclusions were possible. Additional prospective studies and clinical trials are required to more conclusively determine the most appropriate approach for this procedure. IV. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  1. Safety concerns regarding binge drinking in pregnancy: a review.

    Science.gov (United States)

    Conover, Elizabeth Ann; Jones, Kenneth Lyons

    2012-08-01

    There is ongoing debate about the risks to the fetus associated with maternal binge drinking. This makes it difficult to counsel patients about the potential risks associated with their use of alcohol during pregnancy. This article reviews the literature on animal and human studies regarding binge drinking (four to five drinks at one time in humans, or the equivalent in laboratory animals). Animal studies provide evidence that high doses of alcohol over a short period of time can be more damaging than lower doses over a long period of time. Human data are more inconsistent, especially in terms of the association with malformations. Although neurobehavioral effects are the most commonly reported adverse outcome, some studies do not find such an association. Conclusions are confounded by the design of many studies, which fail to document pattern and total amount of alcohol consumption at one time. In addition, it has been suggested there is a bias against the null effect in publications. Although the evidence in humans is not conclusive, the incidence of binge exposures in pregnancy is high, and it appears prudent to counsel patients to avoid this exposure whenever possible. Women inadvertently exposed to a single binge episode of alcohol early in the first trimester before pregnancy recognition can be reassured that the risks for adverse effects in their baby are likely low if they are able to discontinue use for the duration of the pregnancy. Unfortunately, there may be some residual fetal risk. Copyright © 2012 Wiley Periodicals, Inc.

  2. Applying Risk Society Theory to findings of a scoping review on caregiver safety.

    Science.gov (United States)

    Macdonald, Marilyn; Lang, Ariella

    2014-03-01

    Chronic Illness represents a growing concern in the western world and individuals living with chronic illness are primarily managed at home by family caregivers. A scoping review of the home-care literature (2004-2009; updated with review articles from 2010 to January 2013) on the topic of the caregiver revealed that this group experiences the following safety-related concerns: caregivers are conscripted to the role, experience economic hardship, risk being abused as well as abusing, and may well become patients themselves. Methodology and methods used in the scoping review are presented as well as a brief overview of the findings. The concepts of risk and safety are defined. Risk Society Theory is introduced and used as a lens to view the findings, and to contribute to an understanding of the construction of risk in contemporary health-care. © 2013 John Wiley & Sons Ltd.

  3. Review of procedures used for the extraction of anti-cancer compounds from tropical plants.

    Science.gov (United States)

    Pandey, Saurabh; Shaw, Paul N; Hewavitharana, Amitha K

    2015-01-01

    Tropical plants are important sources of anti-cancer lead molecules. According to the US National Cancer Institute, out of the 3000 plants identified as active against cancer using in vitro studies, 70% are of tropical origin. The extraction of bioactive compounds from the plant materials is a fundamental step whose efficiency is critical for the success of drug discovery efforts. There has been no review published of the extraction procedures of anti-cancer compounds from tropical plants and hence the following is a critical evaluation of such procedures undertaken prior to the use of these compounds in cancer cell line studies, during the last five years. It presents a comprehensive analysis of all approaches taken to extract anti-cancer compounds from various tropical plants. (Databases searched were PubMed, SciFinder, Web of Knowledge, Scopus, Embase and Google Scholar).

  4. Comparative Review of Endoscopic Devices Articulations Technologies Developed for Minimally Invasive Medical Procedures

    Directory of Open Access Journals (Sweden)

    Julien Catherine

    2011-01-01

    Full Text Available This study introduces a comparative performance analysis of the technological solutions that have been used to build distal active articulations for minimally invasive medical procedures. The aim is to provide a practical and concise database and classification tool for anyone that wants to learn more about the technologies involved in minimally invasive medical devices, or for any designer interested in further improving these devices. A review of the different articulations developed in this field is therefore performed and organized by both actuation technology and structural architecture. Details are presented concerning the mechanical structures as well as the actuation and the mechanical transmission technologies available. The solutions are evaluated keeping as a reference some chosen required performances and characteristics for minimally invasive surgical procedures. Finally, a quantified comparison chart of these devices is given regarding selected criteria of interest for minimally invasive surgical application.

  5. Identifying nontechnical skills associated with safety in the emergency department: a scoping review of the literature.

    Science.gov (United States)

    Flowerdew, Lynsey; Brown, Ruth; Vincent, Charles; Woloshynowych, Maria

    2012-05-01

    Understanding the nontechnical skills specifically applicable to the emergency department (ED) is essential to facilitate training and more broadly consider interventions to reduce error. The aim of this scoping review is to first identify and then explore in depth the nontechnical skills linked to safety in the ED. The review was conducted in 2 stages. In stage 1, online databases were searched for published empirical studies linking nontechnical skills to safety and performance in the ED. Articles were analyzed to identify key ED nontechnical skills. In stage 2, these key skills were used to generate additional key words, which enabled a second search of the literature to be undertaken and expand on the evidence available for review. In stage 1, 11 articles were retrieved for data analysis and 9 core emergency medicine nontechnical skills were identified. These were communicating, managing workload, anticipating, situational awareness, supervising and providing feedback, leadership, maintaining standards, using assertiveness, and decisionmaking. In stage 2, a secondary search, using these 9 skills and related terms, uncovered a further 21 relevant articles. Therefore, 32 articles were used to describe the main nontechnical skills linked to safety in the ED. This article highlights the challenges of reviewing a topic for which the terms are not clearly defined in the literature. A novel methodological approach is described that provides a structured and transparent process for reviewing the literature in emerging areas of interest. A series of literature reviews focusing on individual nontechnical skills will provide a clearer understanding of how the skills identified contribute to safety in the ED. Copyright © 2011 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

  6. Safety as a management concept in the air transport sector: A systematic literature review

    Directory of Open Access Journals (Sweden)

    Fernando Campa-Planas

    2017-01-01

    Full Text Available Purpose: The main purpose of the present study is to conduct a literature review of the contribution made by safety in air transport, based on the existing international academic literature in the field of the social sciences. It primarily attempts to examine and verify the relationship between safety-related concepts (co-occurrence, the link between the different authors (co-authorship and the corresponding citations (co-citations. Methodology: To achieve the established objectives, a systematic literature review (SLR has been conducted using the Scopus database between the years 1990 and 2016, identifying international academic papers related to the research topic of the present study. Findings: It has been verified, on the one hand, that safety in the air transport sector is a field of growing interest, as the number of papers has increased considerably in recent years, thus demonstrating the importance that this topic has acquired over time. On the other hand, however, it must be mentioned that the total quantity of papers related to the topic is low in terms of absolute numbers. The results of the co-occurrence analysis show that the most important aspect of safety is safety management, while the strongest link is between safety management and aircraft accidents, a fact that is foreseeable a priori.  Originality/value: The approach used allows a better view of the academic contribution made in relation to safety; this serves as the link among the different elements of the concept studied, and it demonstrates the growing interest in this area.

  7. Application of hyperspectral imaging in food safety inspection and control: a review.

    Science.gov (United States)

    Feng, Yao-Ze; Sun, Da-Wen

    2012-01-01

    Food safety is a great public concern, and outbreaks of food-borne illnesses can lead to disturbance to the society. Consequently, fast and nondestructive methods are required for sensing the safety situation of produce. As an emerging technology, hyperspectral imaging has been successfully employed in food safety inspection and control. After presenting the fundamentals of hyperspectral imaging, this paper provides a comprehensive review on its application in determination of physical, chemical, and biological contamination on food products. Additionally, other studies, including detecting meat and meat bone in feedstuffs as well as organic residue on food processing equipment, are also reported due to their close relationship with food safety control. With these applications, it can be demonstrated that miscellaneous hyperspectral imaging techniques including near-infrared hyperspectral imaging, fluorescence hyperspectral imaging, and Raman hyperspectral imaging or their combinations are powerful tools for food safety surveillance. Moreover, it is envisaged that hyperspectral imaging can be considered as an alternative technique for conventional methods in realizing inspection automation, leading to the elimination of the occurrence of food safety problems at the utmost.

  8. The learning curve in learning the curve: a review of Nuss procedure in teenagers.

    Science.gov (United States)

    Ong, Caroline C P; Choo, Kelvin; Morreau, Philip; Auldist, Alex

    2005-06-01

    The Nuss procedure is a new minimally invasive repair for pectus excavatum that was first published in 1998. Modifications in technique are constantly evolving to minimize complications, especially bar displacement, which are higher in adolescents and adults. The present study reviews our early experience with this procedure in a much older group of children than previously reported and suggests an alternative method of avoiding bar displacement. Retrospective chart review was carried out on 78 consecutive patients who underwent the Nuss procedure between December 1999 and January 2004. All patients underwent a uniform technique using bilateral lateral stabilisers and thoracoscopy was not used. Operative details, subjective cosmetic results and complication rates were assessed. The mean age was 15.4 +/- 3.2 years. Single bars were used in 95%, double bars in 5%. The defect was asymmetrical in 26%. The defect was mild in 7%, moderate in 59% and severe in 34%. The median length of stay was 6.0 days (range 4-11). Total operating time was 58 min (range 35-95). Patient controlled analgesia (morphine) for pain relief was used for 105 h (range 61-169) or 4.4 days; the epidural infusion was stopped 1 day earlier. Cosmetic results were excellent in 80.3%. There was residual asymmetry in 75% of the asymmetrical defects although all were improved. Complications included eight (10%) reoperations for bar displacement. This was related to the learning curve as seven of these occurred in the first 2 years of the series. Removal of the bar has been accomplished in 31 (40%) patients. This was elective in all but four patients (three early removals for pain and one for infection). The Nuss procedure gives good results even in teenagers. Modification of technique and increased experience has reduced complications. The use of bilateral lateral stabilisers without additional wire fixation is an alternative method to avoid bar displacement.

  9. Using Health Information Technology to Improve Safety in Neonatal Care: A Systematic Review of the Literature.

    Science.gov (United States)

    Melton, Kristin R; Ni, Yizhao; Tubbs-Cooley, Heather L; Walsh, Kathleen E

    2017-09-01

    Health information technology (HIT) interventions may improve neonatal patient safety but may also introduce new errors. The objective of this review was to evaluate the evidence for use of HIT interventions to improve safety in neonatal care. Evidence for improvement exists for interventions like computerized provider order entry in the neonatal population, but is lacking for several other interventions. Many unique applications of HIT are emerging as technology and use of the electronic health record expands. Future research should focus on the impact of these interventions in the neonatal population. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. The Role of Fear Appeals in Improving Driver Safety: A Review of the Effectiveness of Fear-Arousing (Threat) Appeals in Road Safety Advertising

    Science.gov (United States)

    Lewis, I.; Watson, B.; Tay, R.; White, K. M.

    2007-01-01

    This paper reviews theoretical and empirical evidence relating to the effectiveness of fear (threat) appeals in improving driver safety. The results of the review highlight the mixed and inconsistent findings that have been reported in the literature. While fear arousal appears important for attracting attention, its contribution to behaviour…

  11. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  12. SAFETY

    CERN Document Server

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  13. APPLIED FARM FOOD SAFETY

    OpenAIRE

    Ender, Judit; Mikaczo, Andrea

    2008-01-01

    Recently there have been more and more foodborne illnesses being associated with fresh vegetable produce. In response to this, consumer confidence has been lowered with the safety of the vegetable industry. So, many retailers have recently announced programs requiring growers to have independent third-party inspections. The goal with this essay is to introduce a vegetable farm and reveal its food safety procedures from the seeding through shipping,. reviewing, evaluating, and strengthening cu...

  14. The economic burden of patient safety targets in acute care: a systematic review

    Directory of Open Access Journals (Sweden)

    Mittmann N

    2012-10-01

    Full Text Available Nicole Mittmann,1 Marika Koo,1 Nick Daneman,2 Andrew McDonald,3 Michael Baker,4 Anne Matlow,5 Murray Krahn,6 Kaveh Shojania,7 Edward Etchells71Health Outcomes and Pharmaco Economics (HOPE Research Centre, Division of Clinical Pharmacology, 2Division of Infectious Diseases, 3Quality and Patient Safety, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; 4Patient Safety in Ontario, University Health Network, Toronto, ON, Canada; 5Infection Prevention and Control and Patient Safety, Hospital for Sick Children, Toronto, ON, Canada; 6Toronto Health Economics and Technology Assessment (THETA Collaborative, University of Toronto, Toronto, ON, Canada; 7University of Toronto Centre for Patient Safety, Sunnybrook Health Sciences Centre, Toronto, ON, CanadaBackground: Our objective was to determine the quality of literature in costing of the economic burden of patient safety.Methods: We selected 15 types of patient safety targets for our systematic review. We searched the literature published between 2000 and 2010 using the following terms: “costs and cost analysis,” “cost-effectiveness,” “cost,” and “financial management, hospital.” We appraised the methodologic quality of potentially relevant studies using standard economic methods. We recorded results in the original currency, adjusted for inflation, and then converted to 2010 US dollars for comparative purposes (2010 US$1.00 = 2010 €0.76. The quality of each costing study per patient safety target was also evaluated.Results: We screened 1948 abstracts, and identified 158 potentially eligible studies, of which only 61 (39% reported any costing methodology. In these 61 studies, we found wide estimates of the attributable costs of patient safety events ranging from $2830 to $10,074. In general hospital populations, the cost per case of hospital-acquired infection ranged from $2132 to $15,018. Nosocomial bloodstream infection was associated with costs ranging from $2604 to $22

  15. Work zone safety analysis and modeling: a state-of-the-art review.

    Science.gov (United States)

    Yang, Hong; Ozbay, Kaan; Ozturk, Ozgur; Xie, Kun

    2015-01-01

    Work zone safety is one of the top priorities for transportation agencies. In recent years, a considerable volume of research has sought to determine work zone crash characteristics and causal factors. Unlike other non-work zone-related safety studies (on both crash frequency and severity), there has not yet been a comprehensive review and assessment of methodological approaches for work zone safety. To address this deficit, this article aims to provide a comprehensive review of the existing extensive research efforts focused on work zone crash-related analysis and modeling, in the hopes of providing researchers and practitioners with a complete overview. Relevant literature published in the last 5 decades was retrieved from the National Work Zone Crash Information Clearinghouse and the Transport Research International Documentation database and other public digital libraries and search engines. Both peer-reviewed publications and research reports were obtained. Each study was carefully reviewed, and those that focused on either work zone crash data analysis or work zone safety modeling were identified. The most relevant studies are specifically examined and discussed in the article. The identified studies were carefully synthesized to understand the state of knowledge on work zone safety. Agreement and inconsistency regarding the characteristics of the work zone crashes discussed in the descriptive studies were summarized. Progress and issues about the current practices on work zone crash frequency and severity modeling are also explored and discussed. The challenges facing work zone safety research are then presented. The synthesis of the literature suggests that the presence of a work zone is likely to increase the crash rate. Crashes are not uniformly distributed within work zones and rear-end crashes are the most prevalent type of crashes in work zones. There was no across-the-board agreement among numerous papers reviewed on the relationship between work zone

  16. Ischemic Conditioning as a Hemostatic Intervention in Surgery and Cardiac Procedures: A Systematic Review

    DEFF Research Database (Denmark)

    Krag, Andreas Engel; Hvas, Anne-Mette

    2017-01-01

    Ischemic conditioning induced by nonlethal cycles of tissue ischemia and reperfusion attenuates ischemia–reperfusion injury. The objective of this study is to systematically review the effects of local and remote ischemic conditioning on laboratory parameters of hemostasis and the clinical outcomes...... of thromboembolism or bleeding in patients undergoing surgery or cardiac procedures. PubMed and Embase were searched for relevant human trials published in English between January 1, 1986, and September 7, 2016, and additional studies were identified from reference lists. Data on laboratory parameters of hemostasis...

  17. Safety of transcranial magnetic stimulation: review of international guidelines and new findings

    Directory of Open Access Journals (Sweden)

    N. A. Suponeva

    2017-01-01

    Full Text Available Transcranial magnetic stimulation (TMS is a rapidly developing method of neuromodulation. The use of TMS has increased significantly in both research and clinical practice. This allows not only to better understand this method, but also assess possible risks and consequences for both healthy individuals and patients. In 1998 and 2009 safety, ethical considerations, and application guidelines for the use of TMS in clinical practice and research were published. These recommendations are now the basis for safe application of the method in clinical practice and research. Safety of brain stimulation includes several aspects: the prevention and treatment of adverse effects, the strategy of patient and stimulation protocols selection, as well as safety and monitoring procedures. The most common adverse effects of TMS include headache and neck pain, syncope, transient hearing impairment. The risk of epileptic seizureis extremely low and can be minimized by careful selection of patients and the use of safe stimulation protocols. Careful selection of patients is important, taking into account a large number of factors that influence the risk of adverse effects. These factors are considered in the questionnaires to identify limitations and absolute or relative contraindications to TMS. Another important part of TMS safety is the choice of the stimulation protocol and parameters such as intensity, frequency, duration of one train of stimuli, and the interstimulus interval. Currently, the recommended limits of stimulation parameters are covered in the safety guidelines. It is also necessary to follow the procedure, including the monitoring the patient's condition during TMS and the providing qualified assistance in case of adverse effects.

  18. Technical Letter Report: Evaluation and Analysis of a Few International Periodic Safety Review Summary Reports

    Energy Technology Data Exchange (ETDEWEB)

    Chopra, Omesh K. [Argonne National Lab., IL (United States). Environmental Science Division; Diercks, Dwight R. [Argonne National Lab., IL (United States). Nuclear Engineering Division; Ma, David Chia-Chiun [Argonne National Lab., IL (United States). Environmental Science Division; Garud, Yogendra S. [Argonne National Lab., IL (United States). Environmental Science Division

    2013-12-17

    At the request of the United States (U.S.) government, the International Atomic Energy Agency (IAEA) assembled a team of 20 senior safety experts to review the regulatory framework for the safety of operating nuclear power plants in the United States. This review focused on the effectiveness of the regulatory functions implemented by the NRC and on its commitment to nuclear safety and continuous improvement. One suggestion resulting from that review was that the U.S. Nuclear Regulatory Commission (NRC) incorporate lessons learned from periodic safety reviews (PSRs) performed in other countries as an input to the NRC’s assessment processes. In the U.S., commercial nuclear power plants (NPPs) are granted an initial 40-year operating license, which may be renewed for additional 20-year periods, subject to complying with regulatory requirements. The NRC has established a framework through its inspection, and operational experience processes to ensure the safe operation of licensed nuclear facilities on an ongoing basis. In contrast, most other countries do not impose a specific time limit on the operating licenses for NPPs, they instead require that the utility operating the plant perform PSRs, typically at approximately 10-year intervals, to assure continued safe operation until the next assessment. The staff contracted with Argonne National Laboratory (Argonne) to perform a pilot review of selected translated PSR assessment reports and related documentation from foreign nuclear regulatory authorities to identify any potential new regulatory insights regarding license renewal-related topics and NPP operating experience (OpE). A total of 14 PSR assessment documents from 9 countries were reviewed. For all of the countries except France, individual reports were provided for each of the plants reviewed. In the case of France, three reports were provided that reviewed the performance assessment of thirty-four 900-MWe reactors of similar design commissioned between 1978

  19. Institutional Review Board approval and innovation in urology: current practice and safety issues.

    Science.gov (United States)

    Sundaram, Varun; Vemana, Goutham; Bhayani, Sam B

    2014-02-01

    To retrospectively review recent publications describing novel procedures/techniques, and describe the Institutional Review Board (IRB)/ethics approval process and potential ethical dilemmas in their reporting. We searched PubMed for papers about innovative or novel procedures/techniques between 2011 and August 2012. A query of titles/abstracts in the Journal of Urology, Journal of Endourology, European Urology, BJU International, and Urology identified relevant papers. These results were reviewed for human studies that described an innovative technique, procedure, approach, initial series, and/or used new technology. In all, 91 papers met criteria for inclusion; 25 from the Journal of Endourology, 14 from the Journal of Urology, nine from European Urology, 15 from the BJU International and 28 from Urology. IRB/ethics approval was given for an experimental procedure or database in 24% and 22%, respectively. IRB/ethics approval was not mentioned in 52.7% of studies. Published IRB/ethics approvals for innovative techniques are heterogeneous including database, retrospective, and prospective approvals. Given the concept that innovations are likely not in the legal or ethical standard of care, strong consideration should be given to obtaining IRB/ethics approval before the actual procedure, instead of approval to merely report database outcomes. © 2013 The Authors. BJU International © 2013 BJU International.

  20. Ravitch versus Nuss procedure for pectus excavatum: systematic review and meta-analysis

    Science.gov (United States)

    Kanagaratnam, Aran; Phan, Steven; Tchantchaleishvilli, Vakhtang

    2016-01-01

    Background Pectus excavatum is the most common congenital chest wall deformity. The two most common surgical techniques for its correction are the modified Ravitch technique and the minimally invasive Nuss technique. Despite both procedures being used widely, data comparing them are scarce. Methods We conducted a systematic review and meta-analysis of comparative studies to evaluate these procedures. A systematic search of the literature was performed from six electronic databases. Pooled meta-analysis was conducted using odds ratio (OR) and weighted mean difference (WMD). Results A total of 13 studies comprising 1,432 pediatric (79.3%) and adult (20.7%) patients were identified, including 912 patients undergoing the Nuss procedure compared to 520 patients undergoing the Ravitch procedure. There was no significant difference found between the Nuss group versus Ravitch group in pediatric patients with regard to overall complications (OR =1.16; 95% CI: 0.61–2.19; I2=56%; P=0.65), reoperations (6.1% vs. 6.4%; OR =1.00; 95% CI: 0.40–2.50; I2=0%; P=1.00), wound infections (OR =0.58; 95% CI: 0.23–1.46; I2=0%; P=0.25), hemothorax (1.6% vs. 1.3%; OR =0.74; 95% CI: 0.21–2.65; I2=12%; P=0.64), pneumothorax (3.4% vs. 1.5%; OR =1.11; 95% CI: 0.42–2.93; I2=0%; P=0.83) or pneumonia (OR =0.15; 95% CI: 0.02–1.48; I2=0%; P=0.10). Adult patients undergoing the Nuss procedure had a higher incidence of overall complications (OR =3.26; 95% CI: 1.01–10.46; I2=0%; P=0.05), though there were far fewer studies that reported data. Conclusions These results suggest no difference between the Nuss and Ravitch procedures for pediatric patients, while in adults the Ravitch procedure resulted in fewer complications. PMID:27747174

  1. Road safety effects of porous asphalt: a systematic review of evaluation studies

    DEFF Research Database (Denmark)

    Elvik, R.; Greibe, Poul

    2005-01-01

    This paper presents a systematic review of studies that have evaluated the effects on road safety of porous asphalt. Porous asphalt is widely used on motorways in Europe, mainly in order to reduce traffic noise and increase road capacity. A meta-analysis was made of six studies, containing a total...... of eighteen estimates of the effect of porous asphalt on accident rates. No clear effect on road safety of porous asphalt was found. All summary estimates of effect indicated very small changes in accident rates and very few were statistically significant at conventional levels. Studies that have evaluated...... of these changes in risk factors on accident occurrence cannot be predicted. On the whole, the research that has been reported so far regarding road safety effects of porous asphalt is inconclusive. The studies are not of high quality and the findings are inconsistent....

  2. A Comprehensive Review of Spirit Drink Safety Standards and Regulations from an International Perspective.

    Science.gov (United States)

    Pang, Xiao-Na; Li, Zhao-Jie; Chen, Jing-Yu; Gao, Li-Juan; Han, Bei-Zhong

    2017-03-01

    Standards and regulations related to spirit drinks have been established by different countries and international organizations to ensure the safety and quality of spirits. Here, we introduce the principles of food safety and quality standards for alcoholic beverages and then compare the key indicators used in the distinct standards of the Codex Alimentarius Commission, the European Union, the People's Republic of China, the United States, Canada, and Australia. We also discuss in detail the "maximum level" of the following main contaminants of spirit drinks: methanol, higher alcohols, ethyl carbamate, hydrocyanic acid, heavy metals, mycotoxins, phthalates, and aldehydes. Furthermore, the control measures used for potential hazards are introduced. Harmonization of the current requirements based on comprehensive scope analysis and the risk assessment approach will enhance both the trade and quality of distilled spirits. This review article provides valuable information that will enable producers, traders, governments, and researchers to increase their knowledge of spirit drink safety requirements, control measures, and research trends.

  3. Knowledge, attitudes and practices of food handlers in food safety: An integrative review.

    Science.gov (United States)

    Zanin, Laís Mariano; da Cunha, Diogo Thimoteo; de Rosso, Veridiana Vera; Capriles, Vanessa Dias; Stedefeldt, Elke

    2017-10-01

    This study presents an overview of the relationship between knowledge, attitudes and practices (KAP) of food handlers with training in food safety, in addition to proposing reflections on the training of food handlers, considering its responsibility for food safety and health of consumers. The review was based on the integrative method. The descriptors used were: (food handler), (knowledge, attitudes and practice) and (training). Six databases were searched, 253 articles were consulted and 36 original articles were included. Fifty per cent of the articles pointed that there was no proper translation of knowledge into attitudes/practices or attitudes into practices after training. Knowledge, attitudes and practices of food handlers are important for identifying how efficient training in food safety is allowing prioritize actions in planning training. The evaluation of KAP is the first step to understand the food handler's point of view. After this evaluation other diagnostic strategies become necessary to enhance this understanding. Copyright © 2017. Published by Elsevier Ltd.

  4. Safety of licensed vaccines in HIV-infected persons: a systematic review protocol.

    Science.gov (United States)

    Kagina, Benjamin M; Wiysonge, Charles S; Lesosky, Maia; Madhi, Shabir A; Hussey, Gregory D

    2014-09-11

    Safety of vaccines remains a cornerstone of building public trust on the use of these cost-effective and life-saving public health interventions. In some settings, particularly Sub-Saharan Africa, there is a high prevalence of HIV infection and a high burden of vaccine-preventable diseases. There is evidence suggesting that the immunity induced by some commonly used vaccines is not durable in HIV-infected persons, and therefore, repeated vaccination may be considered to ensure optimal vaccine-induced immunity in this population. However, some vaccines, particularly the live vaccines, may be unsafe in HIV-infected persons. There is lack of evidence on the safety profile of commonly used vaccines among HIV-infected persons. We are therefore conducting a systematic review to assess the safety profile of routine vaccines administered to HIV-infected persons. We will select studies conducted in any setting where licensed and effective vaccines were administered to HIV-infected persons. We will search for eligible studies in PubMed, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Africa-Wide, PDQ-Evidence and CINAHL as well as reference lists of relevant publications. We will screen search outputs, select studies and extract data in duplicate, resolving discrepancies by discussion and consensus. Globally, immunisation is a major public health strategy to mitigate morbidity and mortality caused by various infectious disease-causing agents. In general, there are efforts to increase vaccination coverage worldwide, and for these efforts to be successful, safety of the vaccines is paramount, even among people living with HIV, who in some situations may require repeated vaccination. Results from this systematic review will be discussed in the context of the safety of routine vaccines among HIV-infected persons. From the safety perspective, we will also discuss whether repeat vaccination strategies may be feasible among HIV-infected persons

  5. "Non-filling" procedures for lip augmentation: a systematic review of contemporary techniques and their outcomes.

    Science.gov (United States)

    Moragas, Joan San Miguel; Vercruysse, Herman Junior; Mommaerts, Maurice Y

    2014-09-01

    Ideal lip augmentation techniques have good longevity, low complication rates, and optimal functional and aesthetic results. No systematic review is currently available regarding the efficacy of lip augmentation techniques. This review will focus only on non-filling procedures for lip augmentation (NFPLAs). Current databases Elsevier Science Direct, PubMed, HighWire Press, Springer Standard Collection, SAGE, DOAJ, Sweetswise, Free E-Journals, Ovid Lippincott Williams & Wilkins, Willey Online Library Journals and Cochrane Plus were scrutinized and relevant article reference sections were studied for additional publications. The search heading sequence used was ("Lip" or "Mouth" or "Perioral" or "Nasolabial") and ("Augmentation" or "Enhancement" or "Surgery" or "Lift" or "V-Y" or "Corner"). Exclusion criteria applied to 6436 initial keyword-search retrievals yielded 12 articles. Eight more articles were retrieved from reference sections, for a total of 18 papers assessed. Only one article made a direct comparison of efficacy between two surgical techniques for lip augmentation, and none directly compared complications associated with different NFPLAs. Although this systematic review revealed a lack of quality data in comparing the efficacy and complications among different NFPLAs, it is important to review and pool the existing studies to better suggest proper treatment to patients. Copyright © 2014 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  6. INDEFINITE CONTRACT REVIEW 1999 Procedure for Research Physicists (Professional Category 1)

    CERN Multimedia

    1999-01-01

    In view of the long-standing deliberate turnover policy of professional category 1 research physicists on fixed-term contracts, a special procedure is defined, distinct from the other professional categories. This procedure takes into account that research physicists stay at CERN for only up to 6 years and that periods of service as Fellow may be counted within these six years.The following procedure has been agreed:1.\tThe review covers research physicists holding fixed-term contracts and having completed at least 4 years of service on 30 June 1999. Prior years as Fellow may be taken into consideration in the specific context.\tAll candidates are informed individually.2.\tThe files of all candidates are considered by search committees. The members of the committees are nominated by the Director-General and comprise members of the senior CERN staff as well as at least one senior external physicist. The committees are free to take up references and to interview the candidates.3.\tIn ord...

  7. Effect of music in endoscopy procedures: systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Wang, Man Cai; Zhang, Ling Yi; Zhang, Yu Long; Zhang, Ya Wu; Xu, Xiao Dong; Zhang, You Cheng

    2014-10-01

    Endoscopies are common clinical examinations that are somewhat painful and even cause fear and anxiety for patients. We performed this systematic review and meta-analysis of randomized controlled trials to determine the effect of music on patients undergoing various endoscopic procedures. We searched the Cochrane Library, Issue 6, 2013, PubMed, and EMBASE databases up to July 2013. Randomized controlled trials comparing endoscopies, with and without the use of music, were included. Two authors independently abstracted data and assessed risk of bias. Subgroup analyses were performed to examine the impact of music on different types of endoscopic procedures. Twenty-one randomized controlled trials involving 2,134 patients were included. The overall effect of music on patients undergoing a variety of endoscopic procedures significantly improved pain score (weighted mean difference [WMD] = -1.53, 95% confidence interval [CI] [-2.53, -0.53]), anxiety (WMD = -6.04, 95% CI [-9.61, -2.48]), heart rate (P = 0.01), arterial pressure (P music group, compared with the control group. Furthermore, music had little effect for patients undergoing colposcopy and bronchoscopy in the subanalysis. Our meta-analysis suggested that music may offer benefits for patients undergoing endoscopy, except in colposcopy and bronchoscopy. Wiley Periodicals, Inc.

  8. Cannabis for therapeutic purposes and public health and safety: a systematic and critical review.

    Science.gov (United States)

    Sznitman, Sharon R; Zolotov, Yuval

    2015-01-01

    The use of Cannabis for Therapeutic Purposes (CTP) has recently become legal in many places. These policy and legal modifications may be related to changes in cannabis perceptions, availability and use and in the way cannabis is grown and sold. This may in turn have effects on public health and safety. To better understand the potential effects of CTP legalization on public health and safety, the current paper synthesizes and critically discusses the relevant literature. Twenty-eight studies were identified by a comprehensive search strategy, and their characteristics and main findings were systematically reviewed according to the following content themes: CTP and illegal cannabis use; CTP and other public health issues; CTP, crime and neighbourhood disadvantage. The research field is currently limited by a lack of theoretical and methodological rigorous studies. The review shows that the most prevalent theme of investigation so far has been the relation between CTP and illegal cannabis use. In addition, the literature review shows that there is an absence of evidence to support many common concerns related to detrimental public health and safety effects of CTP legalization. Although lack of evidence provides some reassurance that CTP legalization may not have posed a substantial threat to public health and safety, this conclusion needs to be examined in light of the limitations of studies conducted so far. Furthermore, as CTP policy continues to evolve, including incorporation of greater commercialization, it is possible that the full effects of CTP legalization have yet to take place. Ensuring study quality will allow future research to better investigate the complex role that CTP plays in relation to society at large, and public health and safety in particular. Copyright © 2014 Elsevier B.V. All rights reserved.

  9. Automated discovery of safety and efficacy concerns for joint & muscle pain relief treatments from online reviews.

    Science.gov (United States)

    Adams, David Z; Gruss, Richard; Abrahams, Alan S

    2017-04-01

    Product issues can cost companies millions in lawsuits and have devastating effects on a firm's sales, image and goodwill, especially in the era of social media. The ability for a system to detect the presence of safety and efficacy (S&E) concerns early on could not only protect consumers from injuries due to safety hazards, but could also mitigate financial damage to the manufacturer. Prior studies in the field of automated defect discovery have found industry-specific techniques appropriate to the automotive, consumer electronics, home appliance, and toy industries, but have not investigated pain relief medicines and medical devices. In this study, we focus specifically on automated discovery of S&E concerns in over-the-counter (OTC) joint and muscle pain relief remedies and devices. We select a dataset of over 32,000 records for three categories of Joint & Muscle Pain Relief treatments from Amazon's online product reviews, and train "smoke word" dictionaries which we use to score holdout reviews, for the presence of safety and efficacy issues. We also score using conventional sentiment analysis techniques. Compared to traditional sentiment analysis techniques, we found that smoke term dictionaries were better suited to detect product concerns from online consumer reviews, and significantly outperformed the sentiment analysis techniques in uncovering both efficacy and safety concerns, across all product subcategories. Our research can be applied to the healthcare and pharmaceutical industry in order to detect safety and efficacy concerns, reducing risks that consumers face using these products. These findings can be highly beneficial to improving quality assurance and management in joint and muscle pain relief. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

    Science.gov (United States)

    Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

    2012-01-01

    Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

  11. Review of nuclear power plant safety cable aging studies with recommendations for improved approaches and for future work.

    Energy Technology Data Exchange (ETDEWEB)

    Gillen, Kenneth Todd; Bernstein, Robert

    2010-11-01

    Many U. S. nuclear power plants are approaching 40 years of age and there is a desire to extend their life for up to 100 total years. Safety-related cables were originally qualified for nuclear power plant applications based on IEEE Standards that were published in 1974. The qualifications involved procedures to simulate 40 years of life under ambient power plant aging conditions followed by simulated loss of coolant accident (LOCA). Over the past 35 years or so, substantial efforts were devoted to determining whether the aging assumptions allowed by the original IEEE Standards could be improved upon. These studies led to better accelerated aging methods so that more confident 40-year lifetime predictions became available. Since there is now a desire to potentially extend the life of nuclear power plants way beyond the original 40 year life, there is an interest in reviewing and critiquing the current state-of-the-art in simulating cable aging. These are two of the goals of this report where the discussion is concentrated on the progress made over the past 15 years or so and highlights the most thorough and careful published studies. An additional goal of the report is to suggest work that might prove helpful in answering some of the questions and dealing with some of the issues that still remain with respect to simulating the aging and predicting the lifetimes of safety-related cable materials.

  12. [Psychotherapy and psychological procedures for fibromyalgia syndrome : Updated guidelines 2017 and overview of systematic review articles].

    Science.gov (United States)

    Köllner, V; Bernardy, K; Greiner, W; Krumbein, L; Lucius, H; Offenbächer, M; Sarholz, M; Settan, M; Häuser, W

    2017-06-01

    The regular update of the guidelines on fibromyalgia syndrome, AWMF number 145/004, was scheduled for April 2017. The guidelines were developed by 13 scientific societies and 2 patient self-help organizations coordinated by the German Pain Society. Working groups (n =8) with a total of 42 members were formed balanced with respect to gender, medical expertise, position in the medical or scientific hierarchy and potential conflicts of interest. A systematic search of the literature for systematic reviews of randomized, controlled studies on psychological and psychotherapeutic procedures from December 2010 to May 2016 was performed in the Cochrane library, MEDLINE, PsycINFO and Scopus databases. Levels of evidence were assigned according to the classification system of the Oxford Centre for Evidence-Based Medicine version 2009. The strength of recommendations was achieved by multiple step formalized procedures to reach a consensus. Efficacy, risks, patient preferences and applicability of available therapies were weighed up against each other. The guidelines were reviewed and approved by the board of directors of the societies engaged in the development of the guidelines. Cognitive behavioral therapies received a strong recommendation but biofeedback, guided imagery and hypnosis received a weak recommendation.

  13. Enhancing Patient Safety Event Reporting. A Systematic Review of System Design Features.

    Science.gov (United States)

    Gong, Yang; Kang, Hong; Wu, Xinshuo; Hua, Lei

    2017-08-30

    Electronic patient safety event reporting (e-reporting) is an effective mechanism to learn from errors and enhance patient safety. Unfortunately, the value of e-reporting system (a software or web server based platform) in patient safety research is greatly overshadowed by low quality reporting. This paper aims at revealing the current status of system features, detecting potential gaps in system design, and accordingly proposing suggestions for future design and implementation of the system. Three literature databases were searched for publications that contain informative descriptions of e-reporting systems. In addition, both online publicly accessible reporting forms and systems were investigated. 48 systems were identified and reviewed. 11 system design features and their frequencies of occurrence (Top 5: widgets (41), anonymity or confidentiality (29), hierarchy (20), validator (17), review notification (15)) were identified and summarized into a system hierarchical model. The model indicated the current e-reporting systems are at an immature stage in their development, and discussed their future development direction toward efficient and effective systems to improve patient safety.

  14. The efficacy and safety of feverfew (Tanacetum parthenium L.): an update of a systematic review.

    Science.gov (United States)

    Ernst, E; Pittler, M H

    2000-12-01

    Feverfew (Tanacetum parthenium L.) is a popular herbal remedy often advocated for the prevention of migraine. The aims of this systematic review are to update the evidence from rigorous clinical trials for or against the efficacy of feverfew for migraine prevention and to provide a safety profile of this herbal remedy. Literature searches were performed using the following databases: Medline, Embase, Biosis, CISCOM and the Cochrane Library (all from their inception to December 1999). Only randomized, placebo-controlled, double-blind trials of feverfew mono-preparations for the prevention of migraine in human subjects were included. All articles were read by two independent reviewers. Data were extracted in a pre-defined, standardized fashion. The methodological quality of the trials was evaluated by the Jadad score. For the assessment of safety issues, major reference texts were also consulted. Six trials met the inclusion/exclusion criteria. The majority favour feverfew over placebo. Yet important caveats exist. The data also suggest that feverfew is associated with only mild and transient adverse effects and few other safety concerns. Feverfew is likely to be effective in the prevention of migraine. There are no major safety problems.

  15. Efficacy and safety of laparoscopic mini gastric bypass. A systematic review.

    Science.gov (United States)

    Georgiadou, Despoina; Sergentanis, Theodoros N; Nixon, Alexander; Diamantis, Theodoros; Tsigris, Christos; Psaltopoulou, Theodora

    2014-01-01

    Laparoscopic mini-gastric bypass (LMGB) is a relatively new bariatric procedure; published studies are accumulating in various settings. The objective of this study was to summarize the available evidence about the efficacy and safety of LMGB. A systematic search in the literature was performed , and PubMed and reference lists were scrutinized (end-of-search date: July 15, 2013). For the assessment of the eligible articles, the Newcastle-Ottawa quality assessment scale was used. Ten eligible studies were included in this study, reporting data on 4,899 patients. According to all included studies, LMGB induced substantial weight and body mass index reduction, as well as substantial excess weight loss. Moreover, resolution or improvement in all major associated medical illnesses and improvement in overall Gastrointestinal Quality of Life Index score were recorded. Major bleeding and anastomotic ulcer were the most commonly reported complications. Readmission rate ranged from 0%- 11%, whereas the rate of revision operations ranged from .3%- 6%. The latter were conducted due to a variety of medical reasons such as inadequate or excessive weight loss, malnutrition, and upper gastrointestinal bleeding. Finally, the mortality rate ranged between 0% and .5% among primary LMGB procedures. LMGB represents an effective bariatric procedure; its safety and minimal postoperative morbidity seem remarkable. Randomized comparative studies seem mandatory for the further evaluation of LMGB. Copyright © 2014 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  16. Out-of-Hospital Pediatric Patient Safety Events: Results of the CSI Chart Review.

    Science.gov (United States)

    Meckler, Garth; Hansen, Matthew; Lambert, William; O'Brien, Kerth; Dickinson, Caitlin; Dickinson, Kathryn; Van Otterloo, Joshua; Guise, Jeanne-Marie

    2017-10-12

    Studies of adult hospital patients have identified medical errors as a significant cause of morbidity and mortality. Little is known about the frequency and nature of pediatric patient safety events in the out-of-hospital setting. We sought to quantify pediatric patient safety events in EMS and identify patient, call, and care characteristics associated with potentially severe events. As part of the Children's Safety Initiative -EMS, expert panels independently reviewed charts of pediatric critical ambulance transports in a metropolitan area over a three-year period. Regression models were used to identify factors associated with increased risk of potentially severe safety events. Patient safety events were categorized as: Unintended injury; Near miss; Suboptimal action; Error; or Management complication ("UNSEMs") and their severity and potential preventability were assessed. Overall, 265 of 378 (70.1%) unique charts contained at least one UNSEM, including 146 (32.8%) errors and 199 (44.7%) suboptimal actions. Sixty-one UNSEMs were categorized as potentially severe (23.3% of UNSEMs) and nearly half (45.3%) were rated entirely preventable. Two factors were associated with heightened risk for a severe UNSEM: (1) age 29 days to 11 months (OR 3.3, 95% CI 1.25-8.68); (2) cases requiring resuscitation (OR 3.1, 95% CI 1.16-8.28). Severe UNSEMs were disproportionately higher among cardiopulmonary arrests (8.5% of cases, 34.4% of severe UNSEMs). During high-risk out-of-hospital care of pediatric patients, safety events are common, potentially severe, and largely preventable. Infants and those requiring resuscitation are important areas of focus to reduce out-of-hospital pediatric patient safety events.

  17. A Review of Safety and Design Requirements of the Artificial Pancreas.

    Science.gov (United States)

    Blauw, Helga; Keith-Hynes, Patrick; Koops, Robin; DeVries, J Hans

    2016-11-01

    As clinical studies with artificial pancreas systems for automated blood glucose control in patients with type 1 diabetes move to unsupervised real-life settings, product development will be a focus of companies over the coming years. Directions or requirements regarding safety in the design of an artificial pancreas are, however, lacking. This review aims to provide an overview and discussion of safety and design requirements of the artificial pancreas. We performed a structured literature search based on three search components-type 1 diabetes, artificial pancreas, and safety or design-and extended the discussion with our own experiences in developing artificial pancreas systems. The main hazards of the artificial pancreas are over- and under-dosing of insulin and, in case of a bi-hormonal system, of glucagon or other hormones. For each component of an artificial pancreas and for the complete system we identified safety issues related to these hazards and proposed control measures. Prerequisites that enable the control algorithms to provide safe closed-loop control are accurate and reliable input of glucose values, assured hormone delivery and an efficient user interface. In addition, the system configuration has important implications for safety, as close cooperation and data exchange between the different components is essential.

  18. The economic burden of patient safety targets in acute care: a systematic review.

    Science.gov (United States)

    Mittmann, Nicole; Koo, Marika; Daneman, Nick; McDonald, Andrew; Baker, Michael; Matlow, Anne; Krahn, Murray; Shojania, Kaveh G; Etchells, Edward

    2012-01-01

    Our objective was to determine the quality of literature in costing of the economic burden of patient safety. We selected 15 types of patient safety targets for our systematic review. We searched the literature published between 2000 and 2010 using the following terms: "costs and cost analysis," "cost-effectiveness," "cost," and "financial management, hospital." We appraised the methodologic quality of potentially relevant studies using standard economic methods. We recorded results in the original currency, adjusted for inflation, and then converted to 2010 US dollars for comparative purposes (2010 US$1.00 = 2010 €0.76). The quality of each costing study per patient safety target was also evaluated. We screened 1948 abstracts, and identified 158 potentially eligible studies, of which only 61 (39%) reported any costing methodology. In these 61 studies, we found wide estimates of the attributable costs of patient safety events ranging from $2830 to $10,074. In general hospital populations, the cost per case of hospital-acquired infection ranged from $2132 to $15,018. Nosocomial bloodstream infection was associated with costs ranging from $2604 to $22,414. There are wide variations in the estimates of economic burden due to differences in study methods and methodologic quality. Greater attention to methodologic standards for economic evaluations in patient safety is needed.

  19. A clinical and safety review of paracetamol and ibuprofen in children.

    Science.gov (United States)

    Kanabar, Dipak J

    2017-02-01

    The antipyretic analgesics, paracetamol, and non-steroidal anti-inflammatory agents NSAIDs are one of the most widely used classes of medications in children. The aim of this review is to determine if there are any clinically relevant differences in safety between ibuprofen and paracetamol that may recommend one agent over the other in the management of fever and discomfort in children older than 3 months of age.

  20. Can patients report patient safety incidents in a hospital setting? A systematic review.

    Science.gov (United States)

    Ward, Jane K; Armitage, Gerry

    2012-08-01

    Patients are increasingly being thought of as central to patient safety. A small but growing body of work suggests that patients may have a role in reporting patient safety problems within a hospital setting. This review considers this disparate body of work, aiming to establish a collective view on hospital-based patient reporting. This review asks: (a) What can patients report? (b) In what settings can they report? (c) At what times have patients been asked to report? (d) How have patients been asked to report? 5 databases (MEDLINE, EMBASE, CINAHL, (Kings Fund) HMIC and PsycINFO) were searched for published literature on patient reporting of patient safety 'problems' (a number of search terms were utilised) within a hospital setting. In addition, reference lists of all included papers were checked for relevant literature. 13 papers were included within this review. All included papers were quality assessed using a framework for comparing both qualitative and quantitative designs, and reviewed in line with the study objectives. Patients are clearly in a position to report on patient safety, but included papers varied considerably in focus, design and analysis, with all papers lacking a theoretical underpinning. In all papers, reports were actively solicited from patients, with no evidence currently supporting spontaneous reporting. The impact of timing upon accuracy of information has yet to be established, and many vulnerable patients are not currently being included in patient reporting studies, potentially introducing bias and underestimating the scale of patient reporting. The future of patient reporting may well be as part of an 'error detection jigsaw' used alongside other methods as part of a quality improvement toolkit.

  1. Clinical outcomes of GBR procedures to correct peri-implant dehiscences and fenestrations: a systematic review.

    Science.gov (United States)

    Chiapasco, Matteo; Zaniboni, Marco

    2009-09-01

    To analyze the clinical outcomes of endosseous implants following guided bone regeneration (GBR) procedures to correct dehiscence/fenestration defects associated with implant placement. METHODS/SEARCH STRATEGY: A Medline search was performed for human studies published in English focusing on GBR procedures for the correction of dehiscence/fenestration defects associated with the placement of screw-shaped titanium implants. The selected studies had to include at least 10 consecutively treated patients with a minimum follow-up of 12 months after the start of prosthetic loading. The clinical outcomes in terms of the complication rate of the GBR procedure, implant survival, and stability of marginal soft tissues around implants were evaluated. Seven publications were included in this review. A total of 238 patients received 374 implants. Defects were treated with resorbable or non-resorbable membranes, in association with or without graft materials. Patients were followed for 1-10 years after the start of prosthetic loading. In the postoperative period, 20% of the non-resorbable membranes and 5% of the resorbable ones underwent exposure/infection. However, in the majority of cases, a complete or an almost complete coverage of the initial defect was obtained. The overall survival rate of implants, irrespective of the type of membrane and grafting materials, was 95.7% (range: 84.7-100%). No significant modifications of probing depth and/or variation of clinical attachment level around implants were observed during the follow-up period. Despite the favorable results obtained, it was difficult to draw a significant conclusion as far as the more reliable grafting material and membrane barrier for the correction of dehiscence/fenestration defects are concerned, due to the limited sample of patients and the wide variety of grafting materials and membranes, used alone or in combination. Moreover, due to the lack of randomized clinical trials, it was impossible to demonstrate

  2. Observational Coding Systems of Parent-Child Interactions During Painful Procedures: A Systematic Review.

    Science.gov (United States)

    Bai, Jinbing; Swanson, Kristen M; Santacroce, Sheila J

    2018-01-01

    Parent interactions with their child can influence the child's pain and distress during painful procedures. Reliable and valid interaction analysis systems (IASs) are valuable tools for capturing these interactions. The extent to which IASs are used in observational research of parent-child interactions is unknown in pediatric populations. To identify and evaluate studies that focus on assessing psychometric properties of initial iterations/publications of observational coding systems of parent-child interactions during painful procedures. To identify and evaluate studies that focus on assessing psychometric properties of initial iterations/publications of observational coding systems of parent-child interactions during painful procedures. Computerized databases searched included PubMed, CINAHL, PsycINFO, Health and Psychosocial Instruments, and Scopus. Timeframes covered from inception of the database to January 2017. Studies were included if they reported use or psychometrics of parent-child IASs. First assessment was whether the parent-child IASs were theory-based; next, using the Society of Pediatric Psychology Assessment Task Force criteria IASs were assigned to one of three categories: well-established, approaching well-established, or promising. A total of 795 studies were identified through computerized searches. Eighteen studies were ultimately determined to be eligible for inclusion in the review and 17 parent-child IASs were identified from these 18 studies. Among the 17 coding systems, 14 were suitable for use in children age 3 years or more; two were theory-based; and 11 included verbal and nonverbal parent behaviors that promoted either child coping or child distress. Four IASs were assessed as well-established; seven approached well-established; and six were promising. Findings indicate a need for the development of theory-based parent-child IASs that consider both verbal and nonverbal parent behaviors during painful procedures. Findings also

  3. Cold and compression in the management of musculoskeletal injuries and orthopedic operative procedures: a narrative review

    Directory of Open Access Journals (Sweden)

    Jon E Block

    2010-07-01

    Full Text Available Jon E BlockJon E Block, PhD., Incorporated, San Francisco, CA, USAAbstract: Cold and compression are routinely applied immediately after acute injury or ­following surgery to alleviate pain, reduce swelling and speed functional recovery. The objective of this literature review is to describe the published clinical findings regarding combined cold and compression therapy in the management of musculoskeletal injuries and after orthopedic operative procedures. Of 33 potential articles triaged, the findings of 21 randomized controlled trials were assessed and summarized. The findings reported by these 21 studies were largely subjective pain outcomes and, to a lesser degree, swelling and range of motion, and were inconsistent and divergent, making it difficult to recommend the most appropriate, effective clinical application of cold and compression. Further, 18 of the 21 reported studies evaluated cold and static compression, where the extent and duration of the compression was not uniform within or across studies. Operative procedures may offer a more controlled environment for rigorous investigations. However, such studies must be powered sufficiently to account for variations in surgical procedure that could affect outcomes. More uniform operative procedures, such as total knee arthroplasty, represent a well circumscribed intervention for studying the clinical utility of cold compression therapy because the operative technique is standardized, surgical tissue damage is extensive, intraoperative blood loss is high, and post-operative edema and pain are severe. Findings from randomized controlled trials of knee arthroplasty generally showed cold compression therapy provides better outcomes such as pain relief than alternative interventions. While the effects of cold and static compression are clearly better than no treatment, they do not appear to be directly additive.Keywords: cryotherapy, injury

  4. Impact of safety-related regulatory action on clinical practice: a systematic review.

    Science.gov (United States)

    Piening, Sigrid; Haaijer-Ruskamp, Flora M; de Vries, Jonie T N; van der Elst, Menno E; de Graeff, Pieter A; Straus, Sabine M J M; Mol, Peter G M

    2012-05-01

    After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare professionals. However, the effectiveness of these safety-related regulatory actions is under question. We currently lack a comprehensive overview of the effects of these drug safety warnings on clinical practice to resolve the debate about their effectiveness. The aim of this systematic review is to provide an overview of studies that assessed the impact of safety warnings. A systematic search was performed for articles assessing the impact of Direct Healthcare Professional Communications or 'Dear Doctor' letters, Black Box Warnings and Public Health Advisories on clinical behaviour published between January 1996 and January 2010. The following variables were extracted: publication year, country, name of the drug, safety issue, specific safety warning (Direct Healthcare Professional Communication/Black Box Warning/Public Health Advisory), effect (intended/unintended) of the safety warning, outcome measure and study design. Papers were checked for several quality aspects. Study data were summarized using descriptive analyses. A total of 50 articles were identified. Two articles assessed two different drugs and were therefore counted twice (n = 52). Thirty-three articles described the impact of safety warnings issued for three drugs and drug groups, i.e. third-generation oral contraceptives, cisapride and selective serotonin reuptake inhibitors. The remaining 19 articles described a broad variety of 14 drugs and drug groups. Twenty-five studies applied an interrupted time series design, 23 a controlled or uncontrolled before/after design, and four articles applied both. None of the articles could rule out the influence of confounding factors. The intended effects were reported in 18 (72%) of the 25 before/after analyses, whereas only 11 (41%) of the 27 interrupted time series analyses reported an impact. Only two (8%) of the

  5. Review and assessments of potential environmental, health and safety impacts of MHD technology. Final draft

    Energy Technology Data Exchange (ETDEWEB)

    1978-01-01

    The purpose of this document is to develop an environmental, health and safety (EH and S) assessment and begin a site - specific assessment of these and socio - economic impacts for the magnetohydrodynamics program of the United States Department of Energy. This assessment includes detailed scientific and technical information on the specific EH and S issues mentioned in the MHD Environmental Development Plan. A review of current literature on impact-related subjects is also included. This document addresses the coal-fired, open-cycle MHD technology and reviews and assesses potential EH and S impacts resulting from operation of commercially-installed technology.

  6. Idaho National Laboratory Integrated Safety Management System FY 2013 Effectiveness Review and Declaration Report

    Energy Technology Data Exchange (ETDEWEB)

    Hunt, Farren [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2013-12-01

    Idaho National Laboratory (INL) performed an Annual Effectiveness Review of the Integrated Safety Management System (ISMS), per 48 Code of Federal Regulations (CFR) 970.5223 1, “Integration of Environment, Safety and Health into Work Planning and Execution.” The annual review assessed Integrated Safety Management (ISM) effectiveness, provided feedback to maintain system integrity, and identified target areas for focused improvements and assessments for Fiscal Year (FY) 2014. Results of the FY 2013 annual effectiveness review demonstrate that the INL’s ISMS program is “Effective” and continually improving and shows signs of being significantly strengthened. Although there have been unacceptable serious events in the past, there has also been significant attention, dedication, and resources focused on improvement, lessons learned and future prevention. BEA’s strategy of focusing on these improvements includes extensive action and improvement plans that include PLN 4030, “INL Sustained Operational Improvement Plan, PLN 4058, “MFC Strategic Excellence Plan,” PLN 4141, “ATR Sustained Excellence Plan,” and PLN 4145, “Radiological Control Road to Excellence,” and the development of LWP 20000, “Conduct of Research.” As a result of these action plans, coupled with other assurance activities and metrics, significant improvement in operational performance, organizational competence, management oversight and a reduction in the number of operational events is being realized. In short, the realization of the fifth core function of ISMS (feedback and continuous improvement) and the associated benefits are apparent.

  7. The safety of low melting point bismuth/lead alloys: a review.

    Science.gov (United States)

    Glasgow, G P

    1991-03-01

    Low melting temperature bismuth alloys that contain about 20% to 25% lead and 10% cadmium are widely used in radiotherapy to construct shielding blocks. Since 1980, five papers have addressed questions concerning potential metal toxicity, safe shop practices, measurement of airborne vapors and metal particulates, and the results of biological testing of personnel fabricating secondary field shaping blocks. In February, 1990, the Occupational Safety and Health Administration (OSHA), proposed new occupational air concentration safety standards for cadmium and cadmium compounds. This review presents the potential toxicity of the components metals in low melting temperature bismuth lead alloys, reviews the proposed OSHA air concentrations standards, and describes proper practices of shop safety required to minimize the hazards of these metals and other potentially hazardous materials used in the block fabrication process. The review reveals that if proper practices are followed, fabrication of those blocks, including those containing cadmium, should not produce a shop environment that would produce metal toxicity in employees, and radiotherapy mold room personnel are unlikely to generate air concentrations of cadmium that exceed new proposed standards.

  8. Review of the efficacy and safety of over-the-counter medicine

    Directory of Open Access Journals (Sweden)

    Gerusa Clazer Halila

    2015-06-01

    Full Text Available Over-the-counter medicines are available without prescription because of their safety and effectiveness, to treat minor ailments and symptoms. The objective of the study was to analyze the availability and quality of systematic reviews published about nonprescription medicines, identifying the groups for which there are gaps in evidence. We identified published articles through the Cochrane Database of Systematic Review and MEDLINE, from the start of the database until May 2012, using the search terms "nonprescription drugs," "over the counter," and "OTC." We searched for articles that describe systematic reviews addressing the efficacy and safety of drugs dispensed without a prescription, according to the lists published by the Association of the European Self-Medication Industry and in Brazil, in the clinical conditions listed in Groups and Specified Therapeutic Indications. We included 49 articles, 18 articles were of moderate quality and 31 of high quality. Of the studies, 74.5% demonstrated efficacy in favor of the use of drugs evaluated. Of the 24 studies that evaluated safety, 21% showed evidence unfavorable to the drug. Overall, the evidence found in the studies included in the overview is favorable to the use of the drugs evaluated. However, there are gaps in evidence for some therapy groups.

  9. Which surgical procedure is effective for refractory chronic subdural hematoma? Analysis of our surgical procedures and literature review.

    Science.gov (United States)

    Matsumoto, Hiroaki; Hanayama, Hiroaki; Okada, Takashi; Sakurai, Yasuo; Minami, Hiroaki; Masuda, Atsushi; Tominaga, Shogo; Miyaji, Katsuya; Yamaura, Ikuya; Yoshida, Yasuhisa

    2018-03-01

    Refractory chronic subdural hematoma (CSDH) is rare but remains a difficulty for neurosurgeons, and no consensus on treatment procedures has been established. To discuss effective surgical procedures for refractory CSDH, we analyzed our surgical procedures and outcomes for refractory CSDH. We defined patients with refractory CSDH as those who presented with two or more recurrences. Fourteen patients with refractory CSDH were analyzed. Eight patients underwent burr-hole irrigation and closed-system drainage alone, four patients received embolization of the middle meningeal artery (MMA), and two patients with organized CSDH underwent large craniotomy with outer membranectomy as the third surgery. Two of the eight patients (25%) treated with burr-hole irrigation and drainage alone showed a third recurrence. No further recurrences were identified in patients treated with embolization of the MMA or craniotomy. However, statistical analysis showed no significant difference in cure rate between patients treated with burr-hole irrigation and drainage alone and patients treated with burr-hole irrigation and drainage with embolization of the MMA (P = .42). Similarly, no significant differences in cure rate were seen between patients treated with burr-hole irrigation and drainage alone and patients treated with craniotomy (P = .62). When selecting a surgical procedure, assessing whether the CSDH is organized is crucial. Embolization of the MMA may be considered as one of the optional treatments for refractory CSDH without organized hematoma. On the other hand, for refractory cases of organized CSDH, hematoma evacuation and outer membranectomy with large craniotomy or mini-craniotomy assisted by an endoscope may be suitable, as previous reports have recommended. Copyright © 2017 Elsevier Ltd. All rights reserved.

  10. Tracheostomy decannulation methods and procedures in adults: a systematic scoping review protocol.

    Science.gov (United States)

    Kutsukutsa, John; Mashamba-Thompson, Tivani Phosa; Saman, Yougan

    2017-12-04

    The indications for and the number of tracheostomy procedures has increased with advances in critical care. Studies are indicating likely continued increase in number of tracheostomies. Despite the important benefits of a tracheostomy, its presence is associated with adverse health complications and lowered patient quality of life. Hence, it must be decannulated as soon as it is no longer indicated in a safe and effective manner. There is, however, no agreed universal standard of care for tracheostomy decannulation (TD) in adults. The aims of our study are to systematically map the literature on the decannulation process, reveal knowledge gaps and inform further research. The search strategy of this systematic scoping review will involve the following electronic databases: PubMed/MEDLINE, Google Scholar, Union Catalogue of Theses and Dissertations (UCTD) via SABINET Online and WorldCat Dissertations and Theses via OCLC. Articles will also be searched through the "Cited by" search as well as citations included in the reference lists of included articles. Studies from the databases will be title screened and duplicates removed followed by a parallel two-independent reviewer screening of abstracts followed by full articles of selected studies both guided by eligibility criteria. We will extract data from the included studies and the emerging themes will be analysed. The relationship of the emerging themes to the research question will be critically examined. The quality of the included studies will be determined by Mixed Method Appraisal Tool (MMAT). We will use NVIVO version 10 to extract the relevant outcomes and thematic analysis of the studies. We anticipate to find studies that highlight evidence and preference as well as acceptability of TD methods and procedures. We hope to expose knowledge gaps and inform future research. Findings will be disseminated electronically, in print and through peer presentation, conferences and congresses. Our systematic review has

  11. The Behavioral Avoidance Task with Anxious Youth: A Review of Procedures, Properties, and Criticisms.

    Science.gov (United States)

    Castagna, Peter J; Davis, Thompson E; Lilly, Megan E

    2017-06-01

    The measurement of avoidance behavior in youth with anxiety and related disorders is essential. Historically, the behavioral avoidance task (BAT) has been used as a measure of avoidance that can be tailored to a youth's particular fear. Although in use for over 90 years, there has yet to be a systematic review of its use, properties, etc. Here we examine the use of the BAT with youth as a measure of avoidance over the past 30 years. Studies have used the BAT as a measure of treatment outcome, to explore theories related to avoidance, and provide evidence for the psychometric properties of phobia questionnaires. Specifically, we compare the results of these studies, the purposes of the BAT, and the types of data collected. Results indicated that the BAT might be particularly sensitive to treatment effects. Furthermore, youth with specific phobias can be expected to complete an average of 30% of the BAT at pre-treatment and 60% at post-treatment. These affects have generally been maintained at 6-month follow-ups. Measures of subjective units of distress (SUDS) proved more consistent than steps completed, but more resistant to treatment effects; researchers can expect a SUDS rating of approximately 55% at pre-treatment and 40% at post-treatment. We review the properties and procedures that are used within these studies and provide a critical review. Overall, the BAT is in need of a standardized procedure to allow for psychometric studies to provide evidence of the task's reliability and validity.

  12. Quality and safety in adult epilepsy monitoring units: A systematic review and meta-analysis.

    Science.gov (United States)

    Sauro, Khara M; Wiebe, Natalie; Macrodimitris, Sophie; Wiebe, Samuel; Lukmanji, Sara; Jetté, Nathalie

    2016-11-01

    The epilepsy monitoring unit (EMU) is a valuable resource for optimizing management of persons with epilepsy, but may place patients at risk for adverse events due to withdrawal of treatment and induction of symptoms. The purpose of this study was to synthesize data on the safety and quality of care in EMUs to inform the development of quality indicators for EMUs. A systematic review was conducted according to the Preferred Reporting and Items for Systematic Review and Meta-Analysis (PRISMA) statement. The search strategy, which included broad search terms and synonyms pertaining to the EMU, was run in six medical databases and included conference proceedings. Data abstracted included patient and EMU demographics and quality and safety variables. Study quality was evaluated using a modified 15-item Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist. Descriptive statistics and meta-analyses were used to describe and synthesize the evidence. The search yielded 7,601 references, of which 604 were reviewed in full text. One-hundred thirty-five studies were included. The quality and safety data came from 181,823 patients and reported on 34 different quality and safety variables. Included studies commonly reported the number of patients (108 studies; median number patients, 171.5), age (49 studies; mean age 35.7 years old), and the reason for admission (34 studies). The most common quality and safety data reported were the utility of the EMU admission (38 studies). Thirty-three studies (24.4%) reported on adverse events, and yielded a pooled proportion of adverse events of 7% (95% confidence interval [CI] 5-9%). The mean quality score was 73.3% (standard deviation [SD] 17.2). This study demonstrates that there is a great deal of variation in the reporting of quality and safety measures and in the quality and safety in EMUs. Study quality also varied considerably from one study to the next. These findings highlight the need to develop

  13. Idaho National Laboratory Integrated Safety Management System FY 2016 Effectiveness Review and Declaration Report

    Energy Technology Data Exchange (ETDEWEB)

    Hunt, Farren J. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-12-01

    Idaho National Laboratory’s (INL’s) Integrated Safety Management System (ISMS) effectiveness review of fiscal year (FY) 2016 shows that INL has integrated management programs and safety elements throughout the oversight and operational activities performed at INL. The significant maturity of Contractor Assurance System (CAS) processes, as demonstrated across INL’s management systems and periodic reporting through the Management Review Meeting process, over the past two years has provided INL with current real-time understanding and knowledge pertaining to the health of the institution. INL’s sustained excellence of the Integrated Safety and effective implementation of the Worker Safety and Health Program is also evidenced by other external validations and key indicators. In particular, external validations include VPP, ISO 14001, DOELAP accreditation, and key Laboratory level indicators such as ORPS (number, event frequency and severity); injury/illness indicators such as Days Away, Restricted and Transfer (DART) case rate, back & shoulder metric and open reporting indicators, demonstrate a continuous positive trend and therefore improved operational performance over the last few years. These indicators are also reflective of the Laboratory’s overall organizational and safety culture improvement. Notably, there has also been a step change in ESH&Q Leadership actions that have been recognized both locally and complex-wide. Notwithstanding, Laboratory management continues to monitor and take action on lower level negative trends in numerous areas including: Conduct of Operations, Work Control, Work Site Analysis, Risk Assessment, LO/TO, Fire Protection, and Life Safety Systems, to mention a few. While the number of severe injury cases has decreased, as evidenced by the reduction in the DART case rate, the two hand injuries and the fire truck/ambulance accident were of particular concern. Aggressive actions continue in order to understand the causes and

  14. Periodontal soft tissue non-root coverage procedures: a systematic review from the AAP Regeneration Workshop.

    Science.gov (United States)

    Kim, David M; Neiva, Rodrigo

    2015-02-01

    Gingival augmentation procedures around natural teeth and dental implants are performed to facilitate plaque control, to improve patient comfort, to prevent future recession, and in conjunction with restorative, orthodontic, or prosthetic dentistry. The aim of this study is to answer the most common questions related to this treatment modality based on the most relevant and current knowledge in the field. Two reviewers worked to answer the five most common and clinically relevant questions with supporting literature to understand the role of gingiva around teeth. 1) What circumstances require an increased zone of keratinized tissue (KT), or is KT important? 2) What is the ideal thickness of an autogenous gingival graft? Is a thick autogenous gingival graft more effective than a thin autogenous gingival graft? 3) What are the alternatives to autogenous gingival grafting to increase the zone of attached gingiva? 4) Does orthodontic intervention affect soft tissue health and dimensions? 5) What is the patient-reported patient outcome for minimal KT compared with that for an enhanced zone of KT? An extensive literature search was performed using PubMed, the Cochrane Oral Health Group Specialized Trials Registry (the Cochrane Library), and the most respected journals in the field. Although gingival augmentation procedures were first introduced in 1960s, there have not been in-depth comparative studies examining the five questions that have been proposed by the authors. Lack of relevant systematic reviews and randomized clinical trials (RCTs) on this topic do not allow authors to answer those questions with a strong level of evidence. However, the following can be recommended after reviewing case reports and case series on these topics. 1) There is enough clinical evidence to support maintaining an adequate band of gingiva for intracrevicular margin restoration. 2) Thick grafts do not appear to result in better clinical outcomes than thin grafts. Thick grafts are likely

  15. Feasibility and safety of en bloc resection for primary spine tumors: a systematic review by the Spine Oncology Study Group.

    Science.gov (United States)

    Yamazaki, Tomasato; McLoughlin, Gregory S; Patel, Shreyaskuma; Rhines, Laurence D; Fourney, Daryl R

    2009-10-15

    Systematic review. To determine the general feasibility and safety of en bloc resection for primary spine tumors by analyzing (1) the effect of incisional biopsy performed before definitive en bloc resection and (2) the rate of achievement of disease-free margins, morbidity, mortality, and health resource utilization. The feasibility of en bloc resection is determined by careful surgical and oncologic staging, and a key step in this process is obtaining a tissue diagnosis. There is currently good evidence to support the premise that the best chance for surgical cure in primary tumors of the spine is by en bloc resection with disease-free margins; however, the early morbidity of these procedures begs the question of whether they are justified. A formal systematic review with search of MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews databases was undertaken. Included reports described patients with low grade malignant spine tumors, the method of staging and surgical resection, and the complications. Two blinded, independent reviewers used a standardized study selection worksheet. About 89 articles were identified, with 8 selected after excluding small case series and studies that included other pathologies (e.g., metastatic disease). Weinstein, Boriani, Biagini staging accurately predicted the attainment of wide or marginal en bloc resection in 88% of cases. There was a clear increase in tumor recurrence when intralesional procedures were performed before the definitive en bloc resection. Tumor recurrence significantly shortened patient survival. Surgical complication rates ranged from 13% to 56% and mortality ranged from 0% to 7.7%. (1) Incisional biopsy or intralesional resection significantly increases the risk of local recurrence, therefore, transcutaneous computed tomography-guided trocar biopsy is recommended. When there is a suspicion of primary spine tumor, the surgeon who performs the definitive surgery should ideally perform or direct the

  16. Review of confiscation decisions under the Anti-mafia Law-preventive procedure

    Directory of Open Access Journals (Sweden)

    Lirime Çukaj

    2015-11-01

    Full Text Available The review of final decisions is regarded as an unusual means of appeal aimed at countering a final decision that is considered adjudicated (res judicata. This means of appeal has been provided for in the European Convention on Human Rights, the Constitution of Albania, and the national laws of the Albanian state. Thus, at first sight, the review seems to be in contravention of Article 4 and 34 of the Constitution, the principle of legal certainty. But, in essence, this extraordinary means of appeal attempts to establish effective justice by overturning a wrong decision, despite the fact that this decision has been executed, suspended or terminated. To combat dangerous criminal activities Albania has adopted the Anti-mafia Law, which provides the confiscation of proceeds that are obtained from some of the most dangerous criminal activities such as organized crime, terrorist acts, trafficking, corruption and laundering of crime proceeds. This kind of civil confiscation constituted a novelty in the procedural law and it was imposed when the person was not able to prove the lawful origin of these proceeds obtained from criminal activities. But can these confiscation decisions about the final transfer of property to the state be reviewed? If so, which law shall be applied, the civil or criminal one? This and other answers will be provided in this paper.

  17. Consumer food handling in the home: a review of food safety studies.

    Science.gov (United States)

    Redmond, Elizabeth C; Griffith, Christopher J

    2003-01-01

    Epidemiological data from Europe, North America, Australia, and New Zealand indicate that a substantial proportion of foodborne disease is attributable to improper food preparation practices in consumers' homes. International concern about consumer food safety has prompted considerable research to evaluate domestic food-handling practices. The majority of consumer food safety studies in the last decade have been conducted in the United Kingdom and Northern Ireland (48%) and in the United States (42%). Surveys (questionnaires and interviews), the most frequent means of data collection, were used in 75% of the reviewed studies. Focus groups and observational studies have also been used. One consumer food safety study examined the relationship between pathogenic microbial contamination from raw chicken and observed food-handling behaviors, and the results of this study indicated extensive Campylobacter cross-contamination during food preparation sessions. Limited information about consumers' attitudes and intentions with regard to safe food-handling behaviors has been obtained, although a substantial amount of information about consumer knowledge and self-reported practices is available. Observation studies suggest that substantial numbers of consumers frequently implement unsafe food-handling practices. Knowledge, attitudes, intentions, and self-reported practices did not correspond to observed behaviors, suggesting that observational studies provide a more realistic indication of the food hygiene actions actually used in domestic food preparation. An improvement in consumer food-handling behavior is likely to reduce the risk and incidence of foodborne disease. The need for the development and implementation of food safety education strategies to improve specific food safety behaviors is reviewed in this paper.

  18. Exposure measurement in bicycle safety analysis: A review of the literature.

    Science.gov (United States)

    Vanparijs, Jef; Int Panis, Luc; Meeusen, Romain; de Geus, Bas

    2015-11-01

    Cycling, as an active mode of transportation, has well-established health benefits. However, the safety of cyclists in traffic remains a major concern. In-depth studies of potential risk factors and safety outcomes are needed to ensure the most appropriate actions are taken to improve safety. However, the lack of reliable exposure data hinders meaningful analysis and interpretation. In this paper, we review the bicycle safety literature reporting different methods for measuring cycling exposure and discuss their findings. A literature search identified studies on bicycle safety that included a description of how cycling exposure was measured, and what exposure units were used (e.g. distance, time, trips). Results were analyzed based on whether retrospective or prospective measurement of exposure was used, and whether safety outcomes controlled for exposure. We analyzed 20 papers. Retrospective studies were dominated by major bicycle accidents, whereas the prospective studies included minor and major bicycle accidents. Retrospective studies indicated higher incidence rates (IR) of accidents for men compared to women, and an increased risk of injury for cyclists aged 50 years or older. There was a lack of data for cyclists younger than 18 years. The risk of cycling accidents increased when riding in the dark. Wearing visible clothing or a helmet, or having more cycling experience did not reduce the risk of being involved in an accident. Better cyclist-driver awareness and more interaction between car driver and cyclists, and well maintained bicycle-specific infrastructure should improve bicycle safety. The need to include exposure in bicycle safety research is increasingly recognized, but good exposure data are often lacking, which makes results hard to interpret and compare. Studies including exposure often use a retrospective research design, without including data on minor bicycle accidents, making it difficult to compare safety levels between age categories or

  19. [More than 3 hours and less than 3 years: Safety of anaesthetic procedures in infants less than 3 years old subected to surgery for more the 3 hours].

    Science.gov (United States)

    Álvarez Escudero, Julián; Paredes Esteban, Rosa María; Cambra Lasaosa, Francisco José; Vento, Máximo; López Gil, Maite; de Agustín Asencio, Juan Carlos; Moral Pumarega, María Teresa

    2017-10-01

    An FDA alert in December 2016 on the safety of general anesthesia and sedations in patients less than 3 years of age and pregnant women has raised doubts in relation to the attitude that professionals implicated in these procedures should adopt in relation to these specific group of patients. Confronted with this situation, the following medical scientific societies: Sociedad Española de Anestesia y Reanimación (SEDAR), Sociedad Española de Cirugía Pediátrica (SECP), Sociedad Española de Cuidados Intensivos Pediátricos (SECIP) y Sociedad Española de Neonatología (SENeo), have established a working group to analyze and clarify the safety of these techniques. In the present article we conclude that at present both general anesthesia and profound sedation are considered safe procedures because there is no evidence of the opposite in studies with human beings. However, this ascertained safety should not obviate the problem which still needs to be followed with attention, especially in patients less than 3 years of age undergoing anesthetic procedures for more than 3 hours or prolonged sedation in the Neonatal or Pediatric Intensive Care Units. Copyright © 2017 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

  20. Evaluating the safety and immunogenicity of yellow fever vaccines: a systematic review

    Directory of Open Access Journals (Sweden)

    Thomas RE

    2015-04-01

    Full Text Available Roger E Thomas Department of Family Medicine, G012 Health Sciences Center, University of Calgary Medical School, Calgary, AB, Canada Purpose: To review the safety and immunogenicity of yellow fever vaccines. Literature search: The Cochrane Library (including the Cochrane CENTRAL Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and the NHS Database of Abstracts of Reviews of Effects; MEDLINE; EMBASE; BIOSIS Previews; Global Health; CAB Abstracts; and the Lilacs Database of Latin American and Caribbean literature were searched for individual studies and systematic reviews through January 1, 2015. Results: Six yellow fever vaccines are currently produced, and they are effective against all seven yellow fever virus strains. There is a 99.2% homology of the genome sequences of the six current vaccines. Four systematic reviews identified very small numbers of serious adverse events. A systematic review (updated of all published cases identified 133 serious adverse events that met the Brighton Collaboration criteria: 32 anaphylactic, 42 neurologic (one death, 57 viscerotropic (25 deaths, and two of both neurologic and viscerotropic SAEs. The Sanofi Pasteur Global Pharmacovigilance database reported 276 million doses of Stamaril™ distributed worldwide and identified 12 reports of yellow fever vaccine-associated viscerotropic disease (YEL-AVD, 24 of yellow fever vaccine-associated neurologic disease (YEL-AND, and 33 reports of anaphylaxis (many already published. The Biomanguinhos manufacturer's database reported 110 million doses distributed worldwide between 1999 and 2009, and the rate of YEL-AND was estimated at 0.084/100,000 doses distributed and YEL-AVD at 0.02/100,000 doses distributed. Conclusion: Reports of serious adverse events are mostly from travelers from developed countries, and there is likely serious underreporting for developing countries. On the basis of the published reports, the yellow fever vaccines are

  1. Scalp Cooling: A Literature Review of Efficacy, Safety, and Tolerability for Chemotherapy-Induced Alopecia
.

    Science.gov (United States)

    Ross, Mikel; Fischer-Cartlidge, Erica

    2017-04-01

    More than 75% of patients with cancer cite alopecia as the most feared side effect of treatment, with as many as 10% considering treatment refusal. Despite wide acceptance in other countries, scalp cooling to reduce chemotherapy-induced alopecia (CIA) has been uncommon in the United States because of longstanding concerns of scalp metastases and a lack of reliable efficacy data. 
. This article reviews 40 years of efficacy, safety, and tolerability literature on scalp cooling to prevent CIA. 
. A systematic review was performed in PubMed and CINAHL®. Forty articles were reviewed, with 12 articles demonstrating high levels of evidence and meeting inclusion criteria. Comparative trials, systematic reviews, and one large single-arm trial were included. 
. Scalp cooling efficacy is dependent on many factors but demonstrates better hair preservation than no cooling. No increase in scalp metastases or statistically significant difference in overall survival was seen in retrospective safety data when cooling was used. Few patients discontinue cooling early because of adverse experiences.

  2. Critical review of the current literature on the safety of sucralose.

    Science.gov (United States)

    Magnuson, Bernadene A; Roberts, Ashley; Nestmann, Earle R

    2017-08-01

    Sucralose is a non-caloric high intensity sweetener that is approved globally for use in foods and beverages. This review provides an updated summary of the literature addressing the safety of use of sucralose. Studies reviewed include chemical characterization and stability, toxicokinetics in animals and humans, assessment of genotoxicity, and animal and human feeding studies. Endpoints evaluated include effects on growth, development, reproduction, neurotoxicity, immunotoxicity, carcinogenicity and overall health status. Human clinical studies investigated potential effects of repeated consumption in individuals with diabetes. Recent studies on the safety of sucralose focused on carcinogenic potential and the effect of sucralose on the gut microflora are reviewed. Following the discovery of sweet taste receptors in the gut and studies investigating the activation of these receptors by sucralose lead to numerous human clinical studies assessing the effect of sucralose on overall glycemic control. Estimated daily intakes of sucralose in different population subgroups, including recent studies on children with special dietary needs, consistently find that the intakes of sucralose in all members of the population remain well below the acceptable daily intake. Collectively, critical review of the extensive database of research demonstrates that sucralose is safe for its intended use as a non-caloric sugar alternative. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  3. Feeling lonely in the lab: A literature review and partial examination of recent loneliness induction procedures for experiments

    Directory of Open Access Journals (Sweden)

    Pels Fabian

    2017-01-01

    Full Text Available Few laboratory experiments have been conducted in loneliness research in the past. Therefore, the purpose of this article is to review, partially investigate and discuss loneliness induction procedures in order to facilitate future laboratory experiments in loneliness research (e.g. to examine the link between loneliness and social cognition. Previous studies have found both unconscious (i.e. professional hypnosis and conscious (i.e. recalling and calling out lonely experiences procedures to be successful in inducing loneliness. Another conscious procedure (i.e. recalling and writing down lonely experiences that has been described in recent literature has not yet been examined. Therefore, the present study aimed to examine this procedure using a one-group before-after design. However, this procedure, in which the participants had to recall and write down two lonely situations, was not found to significantly induce loneliness. Of 16 participants, only three reported at least some higher feelings of loneliness following this procedure.

  4. Tourette syndrome and procedures related to dental treatment: a systematic review.

    Science.gov (United States)

    Hansen, Jonas Kjeldbjerg; Jacobsen, Pernille Endrup; Simonsen, Janne Lytoft; Hovgaard, Ole; Haubek, Dorte

    2015-01-01

    Dental treatment of patients with Tourette syndrome (TS) may present special challenges to the dentist. The aim was to systematically review the literature regarding perioperative procedures including sedation and general anaesthesia (GA) of patients with TS. Literature searches were performed in PubMed and Embase to identify papers concerning TS in combination with dental treatment, sedation, and/or GA in order to study outcomes regarding co-morbidity, perioperative complications, and drug interactions. The literature search identified six publications (case reports or series) which addressed the topic. No unexpected adverse effects or drug interactions in relation to sedation or GA in TS patients and no perioperative complications were reported. The literature on TS is scarce and the evidence level is low. Therefore, guidelines regarding the dental treatment of patients with TS cannot be formulated at the present time. © 2014 Special Care Dentistry Association and Wiley Periodicals, Inc.

  5. Non-Respiratory Indications for Polysomnography and Related Procedures in Children: An Evidence-Based Review

    Science.gov (United States)

    Kotagal, Suresh; Nichols, Cynthia D.; Grigg-Damberger, Madeleine M.; Marcus, Carole L.; Witmans, Manisha B.; Kirk, Valerie G.; D'Andrea, Lynn A.; Hoban, Timothy F.

    2012-01-01

    Objective: This evidence-based review provides a systematic and comprehensive review of the literature regarding the utility of polysomnography for the evaluation of non-respiratory sleep disorders in children including hypersomnias, parasomnias, sleep-related movement disorders, and sleep in other special populations. Methods: A task force of pediatric sleep medicine experts performed a systematic review of the literature regarding the use of polysomnography for non-respiratory sleep disorders in children. They identified and graded 76 papers as evidence. Results: The main results include (1) polysomnography combined with the multiple sleep latency test is useful for evaluating disorders of excessive somnolence to objectively quantify sleepiness. The results have to be interpreted with consideration of the pubertal stage and regularity of the sleep patterns of the child; (2) polysomnography is indicated in children with parasomnias or sleep related movement disorders who have a high likelihood of having obstructive sleep apnea (OSA); (3) polysomnography is not routinely indicated in children with enuresis unless there is a high likelihood of OSA; (4) polysomnography can be helpful in evaluating children with restless legs syndrome (RLS) and when periodic limb movement disorder (PLMD) is suspected. Conclusions: These findings suggest that, in children with non-respiratory sleep disorders, polysomnography should be a part of a comprehensive sleep evaluation in selected circumstances to determine the nature of the events in more detail or when the suspicion of OSA is relatively high. Citation: Kotagal S; Nichols CD; Grigg-Damberger MM; Marcus CL; Witmans MB; Kirk VG; D'Andrea LA; Hoban TF. Non-respiratory indications for polysomnography and related procedures in children: an evidence-based review. SLEEP 2012;35(11):1451-1466. PMID:23115394

  6. The outcomes of recent patient safety education interventions for trainee physicians and medical students: a systematic review

    National Research Council Canada - National Science Library

    Kirkman, Matthew A; Sevdalis, Nick; Arora, Sonal; Baker, Paul; Vincent, Charles; Ahmed, Maria

    2015-01-01

    .... A systematic review. Embase, Ovid Medline and PsycINFO databases. Studies including an evaluation of patient safety training interventions delivered to trainees/residents and medical students published between January 2009 and May 2014...

  7. Shoulder Structure and Function Following the Modified Latarjet Procedure: A Clinical and Radiological Review

    Science.gov (United States)

    Garewal, Devinder; Evans, Mathew; Taylor, David; Hoy, Gregory A.; Barwood, Shane; Connell, David

    2013-01-01

    Background To evaluate the clinical and radiological outcomes of the modified Latarjet procedure for traumatic, antero-inferior glenohumeral joint instability. Methods Case series were used with a mean follow-up of 21.3 months for clinical and radiological review and 47.2 months for recurrent instability. Shoulder function was evaluated by clinical examination and validated shoulder scales: Western Ontario Shoulder Stability Index (WOSI), Melbourne Instability Shoulder Score (MISS) and l'Insalata Shoulder Questionnaire. Shoulder structure was evaluated by computed tomography. Results Thirty-two cases were enrolled (mean age 27.0 years). One patient reported a redislocation during the follow-up period. Clinical examination revealed that the median external rotation (at 0° and 90° abduction) was reduced on the operative side by 7.5° (p 0.05). Radiological evaluation revealed a mean (SD) pre-operative glenoid surface area loss of 169.5 (48.5) mm2 reconstituted surgically by a bone block of 225.4 (73.8) mm2. Subscapularis muscle bulk was reduced on the operative side, above the level of the muscle split (p Latarjet procedure reliably restores lost glenoid surface area, shoulder stability, strength and function. A small loss of external rotation is expected and related to altered subscapularis anatomy. PMID:27582905

  8. Nuclear medicine procedures for the evaluation of male sexual organs: a brief review

    Energy Technology Data Exchange (ETDEWEB)

    Bernardo-Filho, Mario; Santos-Filho, Sebastiao David; Fonseca, Adenilson de Souza da [Universidade do Estado do Rio de Janeiro (UERJ), RJ (Brazil). Inst. de Biologia Roberto Alcantara Gomes. Lab. de Radiofarmacia Experimental; Carter, Kevin [Harvard Univ., Boston, MA (United States). Brigham and Women' s Hospital. Dept. of Radiology; Missailidis, Sotiris [The Open University, Milton Keynes (United Kingdom). Dept. of Chemistry and Analytical Sciences

    2008-12-15

    Sexuality consists of three aspects that are interrelated and inseparable, biological, physiological and social. The biological aspect considers the individual's capability to give and to receive pleasure. In consequence, it covers the functionality of the sexual organs and the physiology of human sexual response cycle. Diagnostic imaging modalities, such as single photon emission computed tomography (SPECT) and positron emission tomography (PET) have been used to evaluate clinical disorders of the male reproductive system. PET and SPECT procedures basically involve the administration of a radiopharmaceutical that has a higher uptake in a specific tumor or tissue. The aim of this brief review is to present some radiopharmaceuticals that have been used in the clinical evaluation of the male sexual organs (testes, prostate, seminal vesicles, penis) related with male sexuality. This information could be useful in better understanding the male sexual response cycle, as well as the sexual disorders, when considering the male sexual organs and the pelvic floor. Moreover, the findings obtained with PET and SPECT imaging could help to evaluate the efficacy of clinical results of therapeutic procedures. In conclusion, the knowledge from these images could aid in better understanding the physiology of the different organs related with sexuality. Furthermore, they could be important tools to evaluate the physiological integrity of the involved organs, to improve clinical strategies and to accompany the patients under treatment. (author)

  9. High-density polytetrafluoroethylene membranes in guided bone and tissue regeneration procedures: a literature review.

    Science.gov (United States)

    Carbonell, J M; Martín, I Sanz; Santos, A; Pujol, A; Sanz-Moliner, J D; Nart, J

    2014-01-01

    Expanded polytetrafluoroethylene (e-PTFE) has been used successfully as a membrane barrier for regeneration procedures. However, when exposed to the oral cavity, its high porosity increases the risk of early infection, which can affect surgical outcomes. An alternative to e-PTFE is non-expanded and dense polytetrafluoroethylene (n-PFTE), which results in lower levels of early infection following surgical procedures. The aim of this literature review was to analyze and describe the available literature on n-PFTE, report the indications for use, advantages, disadvantages, surgical protocols, and complications. The medical databases Medline-PubMed and Cochrane Library were searched and supplemented with a hand search for reports published between 1980 and May 2012 on n-PTFE membranes. The search strategy was limited to animal, human, and in vitro studies in dental journals published in English. Twenty-four articles that analyzed the use of n-PTFE as a barrier membrane for guided tissue regeneration and guided bone regeneration around teeth and implants were identified: two in vitro studies, seven experimental studies, and 15 clinical studies. There is limited clinical and histological evidence for the use of n-PTFE membranes at present, with some indications in guided tissue regeneration and guided bone regeneration in immediate implants and fresh extraction sockets. Copyright © 2013 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  10. Soft tissue substitutes in non-root coverage procedures: a systematic review and meta-analysis.

    Science.gov (United States)

    Bertl, Kristina; Melchard, Maximilian; Pandis, Nikolaos; Müller-Kern, Michael; Stavropoulos, Andreas

    2017-03-01

    The present systematic review compared the effectiveness of soft tissue substitutes (STSs) and autogenous free gingival grafts (FGGs) in non-root-coverage procedures to increase keratinized tissue (KT) width around teeth. Included studies fulfilled the following main eligibility criteria: (a) preclinical in vivo or human controlled trials using FGG as control, (b) non-root-coverage procedures, and (c) assessment of KT width. Meta-analysis was performed on the gain in KT width (primary outcome variable) and several secondary variables. Eight human trials with short observation time evaluating five different STSs were identified. FGG yielded consistently significantly (p FGG yielded consistently ≥2 mm KT width postoperatively, while use of STS did not, in the few studies reporting on this outcome. On the other hand, STSs resulted in significantly better aesthetic outcomes and received greater patient preference (p FGG (1) resulted consistently in significantly larger increase in KT width compared to STS and (2) yielded consistently ≥2 mm KT width postoperatively, while STSs did not. STSs yielded significantly better aesthetic outcomes, received greater patient preference, and appeared safe. Larger and more predictable increase in KT width is achieved with FGG, but STSs may be considered when aesthetics is important. Clinical studies reporting relevant posttreatment outcomes, e.g., postop KT width ≥2 mm, on the long-term (>6 months) are warranted.

  11. Procedures for measuring and verifying gastric tube placement in newborns: an integrative review

    Directory of Open Access Journals (Sweden)

    Flávia de Souza Barbosa Dias

    Full Text Available ABSTRACT Objective: to investigate evidence in the literature on procedures for measuring gastric tube insertion in newborns and verifying its placement, using alternative procedures to radiological examination. Method: an integrative review of the literature carried out in the Cochrane, LILACS, CINAHL, EMBASE, MEDLINE and Scopus databases using the descriptors “Intubation, gastrointestinal” and “newborns” in original articles. Results: seventeen publications were included and categorized as “measuring method” or “technique for verifying placement”. Regarding measuring methods, the measurements of two morphological distances and the application of two formulas, one based on weight and another based on height, were found. Regarding the techniques for assessing placement, the following were found: electromagnetic tracing, diaphragm electrical activity, CO2 detection, indigo carmine solution, epigastrium auscultation, gastric secretion aspiration, color inspection, and evaluation of pH, enzymes and bilirubin. Conclusion: the measuring method using nose to earlobe to a point midway between the xiphoid process and the umbilicus measurement presents the best evidence. Equations based on weight and height need to be experimentally tested. The return of secretion into the tube aspiration, color assessment and secretion pH are reliable indicators to identify gastric tube placement, and are the currently indicated techniques.

  12. Patient outcomes and procedure working time for digital versus conventional impressions: A systematic review.

    Science.gov (United States)

    Gallardo, Yolanda R; Bohner, Lauren; Tortamano, Pedro; Pigozzo, Monica N; Laganá, Dalva C; Sesma, Newton

    2017-09-27

    Limited evidence is available comparing digital versus conventional impressions from the point of view of patient preference. The purpose of this systematic review was to identify and summarize the available literature related to patient-centered outcomes for digital versus conventional impression techniques. The databases Medline, Cochrane, Science Direct, Scopus, and Embase were electronically searched and complemented by hand searches. All published papers available on the databases from 1955 to July 2016 were considered for title and abstract analysis. A total of 2943 articles were initially identified through database searches, of which only 5 met the inclusion criteria for qualitative analysis. Four studies comparing patient-reported outcome measures (PROMs) between conventional and digital impressions revealed that the digital technique was more comfortable and caused less anxiety and sensation of nausea. Only 1 study reported no difference between the techniques regardless of patient comfort. Two studies reported a shorter procedure for the conventional technique, whereas 3 studies reported a shorter procedure for the digital technique. A lack of clinical studies addressing patient outcomes regarding digital prosthodontic treatments was observed among the included articles. However, current evidence suggests that patients are more likely to prefer the digital workflow than the conventional techniques. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  13. Electronic Nicotine Delivery Systems (“E-Cigarettes”): Review of Safety and Smoking Cessation Efficacy

    Science.gov (United States)

    Harrell, Paul Truman; Simmons, Vani Nath; Correa, John Bernard; Padhya, Tapan Ashvin; Brandon, Thomas Henry

    2015-01-01

    Background and Objectives Cigarette smoking is common among cancer patients and is associated with negative outcomes. Electronic nicotine delivery systems (“e-cigarettes”) are rapidly growing in popularity and use, but there is limited information on their safety or effectiveness in helping individuals quit smoking. Data Sources The authors searched PubMed, Web of Science, and additional sources for published empirical data on safety and use of electronic cigarettes as an aid to quit smoking. Review Methods We conducted a structured search of the current literature up to and including November 2013. Results E-cigarettes currently vary widely in their contents and are sometimes inconsistent with labeling. Compared to tobacco cigarettes, available evidence suggests that e-cigarettes are often substantially lower in toxic content, cytotoxicity, associated adverse effects, and secondhand toxicity exposure. Data on the use of e-cigarettes for quitting smoking is suggestive, but ultimately inconclusive. Conclusions Clinicians are advised to be aware that the use of e-cigarettes, especially among cigarette smokers, is growing rapidly. These devices are unregulated, of unknown safety, and of uncertain benefit in quitting smoking. Implications for Practice In the absence of further data or regulation, oncologists are advised to discuss the known and unknown safety and efficacy information on e-cigarettes with interested patients, and to encourage patients to first try FDA-approved pharmacotherapies for smoking cessation. PMID:24898072

  14. Safety of contraceptive use among women with peripartum cardiomyopathy: a systematic review.

    Science.gov (United States)

    Tepper, Naomi K; Paulen, Melissa E; Marchbanks, Polly A; Curtis, Kathryn M

    2010-07-01

    Women with peripartum cardiomyopathy (PPCM) have significant health risks during subsequent pregnancies and therefore have a critical need for safe and effective contraception. This systematic review examines evidence regarding the safety of contraceptive use among women with PPCM. We searched the PubMed database for all primary research articles published through February 2009 that addressed the safety of any contraceptive method among women with PPCM or other cardiomyopathy of any type. Of 110 articles that addressed contraceptive safety among women with cardiac disease, three met our inclusion criteria. In these three studies, which included a total of five women with cardiomyopathy, though not specifically PPCM, cases of hypertension, transient ischemic attack (TIA), thromboembolism or heart failure were found among women with cardiac disease who used hormonal methods of contraception including combined oral contraceptives, progestin-only pills and depot medroxyprogesterone acetate. None of the studies reported any cases of cardiovascular complications or infective endocarditis among women with cardiac disease who used intrauterine devices (IUDs). We found no data concerning the safety of contraceptive use among women with PPCM, though we did find limited evidence of hypertension, TIA, thromboembolism and heart failure among women with cardiac disease who used hormonal methods of contraception. None of the studies reported any cases of cardiovascular complications or infective endocarditis among women with cardiac disease who used IUDs. Published by Elsevier Inc.

  15. The U.S. commercial air tour industry: a review of aviation safety concerns.

    Science.gov (United States)

    Ballard, Sarah-Blythe

    2014-02-01

    The U.S. Title 14 Code of Federal Regulations defines commercial air tours as "flight[s] conducted for compensation or hire in an airplane or helicopter where a purpose of the flight is sightseeing." The incidence of air tour crashes in the United States is disproportionately high relative to similar commercial aviation operations, and air tours operating under Part 91 governance crash significantly more than those governed by Part 135. This paper reviews the government and industry response to four specific areas of air tour safety concern: surveillance of flight operations, pilot factors, regulatory standardization, and maintenance quality assurance. It concludes that the government and industry have successfully addressed many of these tenet issues, most notably by: advancing the operations surveillance infrastructure through implementation of en route, ground-based, and technological surveillance methods; developing Aeronautical Decision Making and cue-based training programs for air tour pilots; consolidating federal air tour regulations under Part 136; and developing public-private partnerships for raising maintenance operating standards and improving quality assurance programs. However, opportunities remain to improve air tour safety by: increasing the number and efficiency of flight surveillance programs; addressing pilot fatigue with more restrictive flight hour limitations for air tour pilots; ensuring widespread uptake of maintenance quality assurance programs, especially among high-risk operators not currently affiliated with private air tour safety programs; and eliminating the 25-mile exception allowing Part 91 operators to conduct commercial air tours without the safety oversight required of Part 135 operators.

  16. A Review of Numerical Simulation and Analytical Modeling for Medical Devices Safety in MRI.

    Science.gov (United States)

    Kabil, J; Belguerras, L; Trattnig, S; Pasquier, C; Felblinger, J; Missoffe, A

    2016-11-10

    To review past and present challenges and ongoing trends in numerical simulation for MRI (Magnetic Resonance Imaging) safety evaluation of medical devices. A wide literature review on numerical and analytical simulation on simple or complex medical devices in MRI electromagnetic fields shows the evolutions through time and a growing concern for MRI safety over the years. Major issues and achievements are described, as well as current trends and perspectives in this research field. Numerical simulation of medical devices is constantly evolving, supported by calculation methods now well-established. Implants with simple geometry can often be simulated in a computational human model, but one issue remaining today is the experimental validation of these human models. A great concern is to assess RF heating on implants too complex to be traditionally simulated, like pacemaker leads. Thus, ongoing researches focus on alternative hybrids methods, both numerical and experimental, with for example a transfer function method. For the static field and gradient fields, analytical models can be used for dimensioning simple implants shapes, but limited for complex geometries that cannot be studied with simplifying assumptions. Numerical simulation is an essential tool for MRI safety testing of medical devices. The main issues remain the accuracy of simulations compared to real life and the studies of complex devices; but as the research field is constantly evolving, some promising ideas are now under investigation to take up the challenges.

  17. Spinal cord stimulation: a review of the safety literature and proposal for perioperative evaluation and management.

    Science.gov (United States)

    Walsh, Kevin M; Machado, Andre G; Krishnaney, Ajit A

    2015-08-01

    There is currently no consensus on appropriate perioperative management of patients with spinal cord stimulator implants. Magnetic resonance imaging (MRI) is considered safe under strict labeling conditions. Electrocautery is generally not recommended in these patients but sometimes used despite known risks. The aim was to discuss the perioperative evaluation and management of patients with spinal cord stimulator implants. A literature review, summary of device labeling, and editorial were performed, regarding the safety of spinal cord stimulator devices in the perioperative setting. A literature review was performed, and the labeling of each Food and Drug Administration (FDA)-approved spinal cord stimulation system was reviewed. The literature review was performed using PubMed and the FDA website (www.fda.gov). Magnetic resonance imaging safety recommendations vary between the models. Certain systems allow for MRI of the brain to be performed, and only one system allows for MRI of the body to be performed, both under strict labeling conditions. Before an MRI is performed, it is imperative to ascertain that the system is intact, without any lead breaks or low impedances, as these can result in heating of the spinal cord stimulation (SCS) and injury to the patient. Monopolar electrocautery is generally not recommended for patients with SCS; however, in some circumstances, it is used when deemed required by the surgeon. When cautery is necessary, bipolar electrocautery is recommended. Modern electrocautery units are to be used with caution as there remains a risk of thermal injury to the tissue in contact with the SCS. As with MRI, electrocautery usage in patients with SCS systems with suspected breaks or abnormal impedances is unsafe and may cause injury to the patient. Spinal cord stimulation is increasingly used in patients with pain of spinal origin, particularly to manage postlaminectomy syndrome. Knowledge of the safety concerns of SCS and appropriate

  18. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

    Science.gov (United States)

    Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

    2015-01-01

    Aims Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). Methods We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA’s 210 day regulatory deadline. Results Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276–406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Conclusions Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. PMID:25808713

  19. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

    Science.gov (United States)

    Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

    2015-10-01

    Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA's 210 day regulatory deadline. Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276-406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. © 2015 The British Pharmacological Society.

  20. Can We Do That Here? Establishing the Scope of Surgical Practice at a New Safety-Net Community Hospital Through a Transparent, Collaborative Review of Physician Privileges.

    Science.gov (United States)

    O'Neill, Sean M; Seresinghe, Sarah; Sharma, Arun; Russell, Tara A; Crawford, L'Orangerie; Frencher, Stanley K

    2018-01-01

    Stewarding of physician privileges wisely is imperative, but no guidelines exist for how to incorporate system-level factors in privileging decisions. A newly opened, safety-net community hospital tailored the scope of surgical practice through review of physician privileges. Martin Luther King, Jr. Community Hospital is a public-private partnership, safety-net institution in South Los Angeles that opened in July 2015. It has 131 beds, including a 28-bed emergency department, a 20-bed ICU, and 5 operating rooms. Staff privileging decisions were initially based only on physicians' training and experience, but this resulted in several cases that tested the boundaries of what a small community hospital was prepared to handle. A collaborative, transparent process to review physician privileges was developed. This began with physician-only review of procedure lists, followed by a larger, multidisciplinary group to assess system-level factors. Specific questions were used to guide discussion, and unanimous approval from all stakeholders was required to include a procedure. An initial list of 558 procedures across 11 specialties was reduced to 321 (57.5%). No new cases that fall outside these new boundaries have arisen. An inclusive process was crucial for obtaining buy-in and establishing cultural norms. Arranging transfer agreements remains a significant challenge. Accumulation of institutional experience continues through regular performance reviews. As this hospital's capabilities mature, a blueprint has been established for expanding surgical scope of practice based explicitly on system-level factors. Copyright © 2017 The Joint Commission. Published by Elsevier Inc. All rights reserved.

  1. [Complementary and alternative procedures for fibromyalgia syndrome : Updated guidelines 2017 and overview of systematic review articles].

    Science.gov (United States)

    Langhorst, J; Heldmann, P; Henningsen, P; Kopke, K; Krumbein, L; Lucius, H; Winkelmann, A; Wolf, B; Häuser, W

    2017-06-01

    The regular update of the guidelines on fibromyalgia syndrome, AWMF number 145/004, was scheduled for April 2017. The guidelines were developed by 13 scientific societies and 2 patient self-help organizations coordinated by the German Pain Society. Working groups (n =8) with a total of 42 members were formed balanced with respect to gender, medical expertise, position in the medical or scientific hierarchy and potential conflicts of interest. A search of the literature for systematic reviews of randomized controlled trials of complementary and alternative therapies from December 2010 to May 2016 was performed in the Cochrane library, MEDLINE, PsycINFO and Scopus databases. Levels of evidence were assigned according to the classification system of the Oxford Centre for Evidence-Based Medicine version 2009. The strength of recommendations was formed by multiple step formalized procedures to reach a consensus. Efficacy, risks, patient preferences and applicability of available therapies were weighed up against each other. The guidelines were reviewed and approved by the board of directors of the societies engaged in the development of the guidelines. Meditative movement therapies (e.g. qi gong, tai chi and yoga) are strongly recommended. Acupuncture and weight reduction in cases of obesity can be considered.

  2. Formalising multidisciplinary peer review: developing a haematological malignancy-specific electronic proforma and standard operating procedure to facilitate procedural efficiency and evidence-based clinical practice.

    Science.gov (United States)

    Trotman, Judith; Trinh, Jimmy; Kwan, Yiu Lam; Estell, Jane A; Fletcher, Julie; Archer, Kate; Lee, Kenneth; Foo, Kerwin; Curnow, Jennifer; Bianchi, Alessandra; Wignall, Lynda; Verner, Emma; Gasiorowski, Robin; Siedlecka, Elizabeth; Cunningham, Ilona

    2017-05-01

    Multidisciplinary team (MDT) meetings aimed at facilitating peer review have become standard practice in oncology. However, there is scant literature on the optimal structure and conduct of such meetings. To develop a process for formal peer review of patients with haematological malignancies and to audit any resulting changes made to the management recommendations of the treating physician. A standard operating procedure (SOP) for MDT meetings was developed essentially to integrate clinical peer review with weekly pathology and radiology meetings. The centrepiece is the electronic submission of a patient-specific proforma (Microsoft InfoPath) prior to the meeting. It serves as the template for presentation, discussion and recording of recommendations and conclusions. The final verified document is stored in the electronic patient record, and a copy is sent to the general practitioner. The proposed management plans were compared to the consensus recommendations of the meeting for the first 4 years since inception. Both SOP and proforma underwent continual improvements. These provided the framework for the conduct of a robust weekly MDT meeting for peer review of the management of patients with haematological malignancies. On 20% of occasions, patient management plans were altered to optimise patient care as a direct consequence on peer review at the MDT. Our streamlined process, in its ultimate format, has provided a mature and efficient forum for formal peer review in a genuine multidisciplinary environment. Both initial data and informal feedback support its ongoing activity as an integral component of delivering quality patient care. © 2016 Royal Australasian College of Physicians.

  3. Efficacy, safety and immunogenicity of biosimilars in inflammatory bowel diseases: A systematic review.

    Science.gov (United States)

    Martelli, Laura; Peyrin-Biroulet, Laurent

    2016-10-14

    Anti-tumor necrosis factor (anti-TNF) monoclonal antibodies have revolutionized the treatment of inflammatory bowel diseases (IBD). However, because of their complexity, their production is expensive contributing to their high price. As the patent protection of these therapies has expired in several countries, biosimilars have been developed to reduce the healthcare costs. The aim of this article is to review the literature on the safety, efficacy and immunogenicity of biosimilars in IBD. A PubMed literature search was performed using the following terms until May 2016: 'biosimilars', 'CT-P13', 'infliximab', 'Crohn's disease', 'ulcerative colitis', 'inflammatory bowel diseases', 'efficacy', 'safety', 'immunogenicity'. Additionally, abstracts from international meetings were also reviewed. A total of eleven studies in IBD patients provided real-world evidence on the efficacy, safety and immunogenicity profile of biosimilars in IBD patients. Based on available evidence, CT-P13 is efficacious and well tolerated in IBD patients in a real-life setting. The vast majority of studies only included IBD patients who had never received biological therapies. Information regarding the interchangeability between CT-P13 and its originator is currently being investigated in the NOR-SWITCH trial. Otherwise, the immunogenicity profile of CT-P13 seems to be similar to the originator. The infliximab biosimilar seems to be efficacious, safe and with a similar immunogenicity profile as the originator in IBD. Large prospective post-marketing studies are needed to assess the long-term safety profile of CT-P13. The use of infliximab biosimilars may lead to major healthcare cost savings.

  4. How Effective Are Incident-Reporting Systems for Improving Patient Safety? A Systematic Literature Review

    Science.gov (United States)

    Stavropoulou, Charitini; Doherty, Carole; Tosey, Paul

    2015-01-01

    Context Incident-reporting systems (IRSs) are used to gather information about patient safety incidents. Despite the financial burden they imply, however, little is known about their effectiveness. This article systematically reviews the effectiveness of IRSs as a method of improving patient safety through organizational learning. Methods Our systematic literature review identified 2 groups of studies: (1) those comparing the effectiveness of IRSs with other methods of error reporting and (2) those examining the effectiveness of IRSs on settings, structures, and outcomes in regard to improving patient safety. We used thematic analysis to compare the effectiveness of IRSs with other methods and to synthesize what was effective, where, and why. Then, to assess the evidence concerning the ability of IRSs to facilitate organizational learning, we analyzed studies using the concepts of single-loop and double-loop learning. Findings In total, we identified 43 studies, 8 that compared IRSs with other methods and 35 that explored the effectiveness of IRSs on settings, structures, and outcomes. We did not find strong evidence that IRSs performed better than other methods. We did find some evidence of single-loop learning, that is, changes to clinical settings or processes as a consequence of learning from IRSs, but little evidence of either improvements in outcomes or changes in the latent managerial factors involved in error production. In addition, there was insubstantial evidence of IRSs enabling double-loop learning, that is, a cultural change or a change in mind-set. Conclusions The results indicate that IRSs could be more effective if the criteria for what counts as an incident were explicit, they were owned and led by clinical teams rather than centralized hospital departments, and they were embedded within organizations as part of wider safety programs. PMID:26626987

  5. Safety classification of herbal medicines used among pregnant women in Asian countries: a systematic review.

    Science.gov (United States)

    Ahmed, Mansoor; Hwang, Jung Hye; Choi, Soojeung; Han, Dongwoon

    2017-11-14

    High prevalence of herbal medicines used in pregnancy and the lack of information on their safety is a public concern. Despite this, no significant research has been done regarding potential adverse effects of using herbal medicines during pregnancy, especially among developing Asian countries. Cross-sectional studies were searched up to year 2016 on PubMed/Medline and EMBASE, the data were extracted and quality of studies was assessed using the quality appraisal tool. The findings are reported in accordance to the PRISMA checklist (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Classification on safety of identified herbal medicines was done based on current scientific literature. This study included eight cross-sectional studies (2729 participants) from seven different Asian countries, of which 1283 (47.01%) women used one or more herbal medicines during pregnancy. Peppermint (22.8%), aniseed (14.7%), olibanum (12.9%), flixweed seed (12.2%) and ginger (11.5%) were the most frequently used herbal medicines. Out of the 33 identified herbal medicines, 13 were classified as safe to use, five as use with caution, eight were potentially harmful to use in pregnancy and information on seven herbal medicines was not available in the current literature. Several herbal medicines identified in this review were classified to be potentially harmful or the information regarding safety in pregnancy was missing. It is recommended that contraindicated herbal medicines should be avoided and other herbals should be taken under supervision of a qualified health care practitioner. The classification regarding safety of herbal medicines in pregnancy can be utilized to create awareness on prevention of adverse effects.

  6. Safety of vaccines used for routine immunization of U.S. children: a systematic review.

    Science.gov (United States)

    Maglione, Margaret A; Das, Lopamudra; Raaen, Laura; Smith, Alexandria; Chari, Ramya; Newberry, Sydne; Shanman, Roberta; Perry, Tanja; Goetz, Matthew Bidwell; Gidengil, Courtney

    2014-08-01

    Concerns about vaccine safety have led some parents to decline recommended vaccination of their children, leading to the resurgence of diseases. Reassurance of vaccine safety remains critical for population health. This study systematically reviewed the literature on the safety of routine vaccines recommended for children in the United States. Data sources included PubMed, Advisory Committee on Immunization Practices statements, package inserts, existing reviews, manufacturer information packets, and the 2011 Institute of Medicine consensus report on vaccine safety. We augmented the Institute of Medicine report with more recent studies and increased the scope to include more vaccines. Only studies that used active surveillance and had a control mechanism were included. Formulations not used in the United States were excluded. Adverse events and patient and vaccine characteristics were abstracted. Adverse event collection and reporting was evaluated by using the McHarm scale. We were unable to pool results. Strength of evidence was rated as high, moderate, low, or insufficient. Of 20 478 titles identified, 67 were included. Strength of evidence was high for measles/mumps/rubella (MMR) vaccine and febrile seizures; the varicella vaccine was associated with complications in immunodeficient individuals. There is strong evidence that MMR vaccine is not associated with autism. There is moderate evidence that rotavirus vaccines are associated with intussusception. Limitations of the study include that the majority of studies did not investigate or identify risk factors for AEs; and the severity of AEs was inconsistently reported. We found evidence that some vaccines are associated with serious AEs; however, these events are extremely rare and must be weighed against the protective benefits that vaccines provide. Copyright © 2014 by the American Academy of Pediatrics.

  7. Use and implementation of standard operating procedures and checklists in prehospital emergency medicine: a literature review.

    Science.gov (United States)

    Chen, Chulin; Kan, Ting; Li, Shuang; Qiu, Chen; Gui, Li

    2016-12-01

    This review aimed to analyze published literature to introduce the use and implementation of standard operating procedures (SOPs) and checklists in prehospital emergency medicine and their impact on guideline adherence and patient outcome. An English literature search was carried out using the Cochrane Library, MEDLINE, EMBASE, Springer, Elsevier, and ProQuest databases. Original articles describing the use and implementation of SOPs or checklists in prehospital emergency medicine were included. Editorials, comments, letters, bulletins, news articles, conference abstracts, and notes were excluded from the analysis. Relevant information was extracted relating to application areas, development of SOPs/checklists, educational preparation and training regarding SOPs/checklists implementation, staff attitudes and the effects of SOPs/checklists use on guideline adherence and patient outcomes. The literature search found 2187 potentially relevant articles, which were narrowed down following an abstract review and a full text review. A final total of 13 studies were identified that described the use and implementation of SOPs (9 studies) and checklists (4 studies) in different areas of prehospital emergency medicine including prehospital management of patients with acute exacerbated chronic obstructive pulmonary disease and acute coronary syndrome, prehospital airway management, medical documentation, Emergency Medical Services triage, and transportation of patients. The use and implementation of SOPs and checklists in prehospital emergency medicine have shown some benefits of improving guidelines adherence and patient outcomes in airway management, patient records, identification and triage, and other prehospital interventions. More research in this area is necessary to optimize the future use and implementation of SOPs and checklists to improve emergency personnel performance and patient outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Safety and Efficacy Profile of Commercial Veterinary Vaccines against Rift Valley Fever: A Review Study

    Directory of Open Access Journals (Sweden)

    Moataz Alhaj

    2016-01-01

    Full Text Available Rift Valley Fever (RVF is an infectious illness with serious clinical manifestations and health consequences in humans as well as a wide range of domestic ruminants. This review provides significant information about the prevention options of RVF along with the safety-efficacy profile of commercial vaccines and some of RVF vaccination strategies. Information presented in this paper was obtained through a systematic investigation of published data about RVF vaccines. Like other viral diseases, the prevention of RVF relies heavily on immunization of susceptible herds with safe and cost-effective vaccine that is able to confer long-term protective immunity. Several strains of RVF vaccines have been developed and are available in commercial production including Formalin-Inactivated vaccine, live attenuated Smithburn vaccine, and the most recent Clone13. Although Formalin-Inactivated vaccine and live attenuated Smithburn vaccine are immunogenic and widely used in prevention programs, they proved to be accompanied by significant concerns. Despite Clone13 vaccine being suggested as safe in pregnant ewes and as highly immunogenic along with its potential for differentiating infected from vaccinated animals (DIVA, a recent study raised concerns about the safety of the vaccine during the first trimester of gestation. Accordingly, RVF vaccines that are currently available in the market to a significant extent do not fulfill the requirements of safety, potency, and DIVA. These adverse effects stressed the need for developing new vaccines with an excellent safety profile to bridge the gap in safety and immunity. Bringing RVF vaccine candidates to local markets besides the absence of validated serological test for DIVA remain the major challenges of RVF control.

  9. Integrating natural language processing expertise with patient safety event review committees to improve the analysis of medication events.

    Science.gov (United States)

    Fong, Allan; Harriott, Nicole; Walters, Donna M; Foley, Hanan; Morrissey, Richard; Ratwani, Raj R

    2017-08-01

    Many healthcare providers have implemented patient safety event reporting systems to better understand and improve patient safety. Reviewing and analyzing these reports is often time consuming and resource intensive because of both the quantity of reports and length of free-text descriptions in the reports. Natural language processing (NLP) experts collaborated with clinical experts on a patient safety committee to assist in the identification and analysis of medication related patient safety events. Different NLP algorithmic approaches were developed to identify four types of medication related patient safety events and the models were compared. Well performing NLP models were generated to categorize medication related events into pharmacy delivery delays, dispensing errors, Pyxis discrepancies, and prescriber errors with receiver operating characteristic areas under the curve of 0.96, 0.87, 0.96, and 0.81 respectively. We also found that modeling the brief without the resolution text generally improved model performance. These models were integrated into a dashboard visualization to support the patient safety committee review process. We demonstrate the capabilities of various NLP models and the use of two text inclusion strategies at categorizing medication related patient safety events. The NLP models and visualization could be used to improve the efficiency of patient safety event data review and analysis. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Xie Cheng-long

    2013-01-01

    Full Text Available Abstract Background Insomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD is a well known classic Chinese herbal prescription for insomnia and has been treating people’s insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia. Methods A systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions. Results Twelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusions Despite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well

  11. The safety of candidate vaginal microbicides since nonoxynol-9: a systematic review of published studies.

    Science.gov (United States)

    Poynten, I Mary; Millwood, Iona Y; Falster, Michael O; Law, Matthew G; Andresen, David N; Van Damme, Lut; Kaldor, John M

    2009-06-19

    To gain a greater understanding of published safety data for candidate vaginal microbicides. A systematic review of human safety trials of candidate vaginal microbicides - agents designed to protect women against HIV and other sexually transmitted infections. Trials were published in peer-reviewed journals, and publication cut-off was August week 4, 2008. Trials of nonoxynol-9 were excluded, as were trials without a control group, trials that enrolled only male participants or reported on the investigation of a product for the treatment of a genital infection. Twenty-one trials of 11 products, involving 1465 women, satisfied review criteria. Most trials reported on genital epithelial findings and urogenital symptoms and a number reported a range of other local and systemic toxicity endpoints. Trials were generally of short duration (2 weeks or less) with small sample sizes. There were few findings of significant difference between women in active and control arms. Among the products assessed in more than one study, there were significantly more genital findings with intact epithelium in recipients of PRO2000 [relative risk (RR) 1.68, 95% confidence interval (CI) 1.08-2.60] and a lower incidence of bacterial vaginosis in dextrin sulphate recipients (RR 0.61, 95% CI 0.42-0.88). CIs were generally very wide, and most studies were unable to exclude differences of a substantial magnitude between treated and control women. Larger and longer safety studies are necessary to detect clinically important toxicities, including those that indicate a potential increase in HIV risk, and provide assurance that agents are ready for large-scale effectiveness trials.

  12. The safety of donor skin preserved with glycerol - Evaluating the Euro Skin Bank preservation procedures of human donor skin against the prEN 12442 standard

    NARCIS (Netherlands)

    Geertsma RE; Wassenaar C; LGM

    2000-01-01

    The procedures for preservation of human donor skin with glycerol, as applied by the Euro Skin Bank (ESB), were evaluated against the prEN 12442 standard: animal tissues and their derivatives used in the manufacture of medical devices. The focus chosen for this review is on risks related to the

  13. Experiences from the LNPP-P and DSA review. Lessons learned from RBMK safety studies

    Energy Technology Data Exchange (ETDEWEB)

    Mankamo, T. [Avaplan Oy (Finland); Marttila, J.; Reponen, H. [Radiation and Nuclear Safety Authority, Helsinki (Finland)

    2000-09-01

    RBMK is the Russian acronym for 'Channelized Large Power Reactor'. The Soviet-designed RBMK plants deviate substantially from typical Western BWR or PWR plants. The safety of the RBMK plants has raised severe concerns since the major accident at Chernobyl Unit 4 in 1986. In addition, a fire destroyed the turbine hall of Chernobyl Unit 2 in 1991 resulting in a near-accident: the reactor cooling could only be maintained through improvised measures. Another well-known fire event is the control cable room fire at Ignalina Unit 2 in 1989, which led to a partial loss of the main control room functions. After the collapse of Soviet Union several multilateral safety programs were started to evaluate and improve the safety of the RBMK plants. A Probabilistic and Deterministic Safety Assessment (P and DSA) of the Leningrad Nuclear Power Plant (LNPP) Unit 2 was started in 1996. Phase 2 of the project was completed in January 1999. A Peer Review was performed by Russian and Western experts. This report describes the insights from the RBMK risk studies, especially from the LNPP P and DSA with emphasis on the deeper understanding of the risk-important design factors and identification of possible ways to increase safety. LNPP P and DSA has meant a significant progress in this respect. Despite of its certain limitations P and DSA Phase 2 could point out short-term measures, which substantially reduced the risk of identified weaknesses, mostly related to the reliability of the emergency feedwater function and its support systems. The findings of LNPP P and DSA and the review recommendations emphasise the extensions needed to the analysis scope. The spreading and other influences of fires and floods between connected spaces should be analysed because of incomplete separation and protection in these regards in the 16st generation RBMK plants. High priority should be given to the analysis of external hazards, which were found important at the Loviisa NPP on the Northern

  14. Critical review of the reactor-safety study radiological health effects model. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Cooper, D.W.; Evans, J.S.; Jacob, N.; Kase, K.R.; Maletskos, C.J.; Robertson, J.B.; Smith, D.G.

    1983-03-01

    This review of the radiological health effects models originally presented in the Reactor Safety Study (RSS) and currently used by the US Nuclear Regulatory Commission (NRC) was undertaken to assist the NRC in determining whether or not to revise the models and to aid in the revision, if undertaken. The models as presented in the RSS and as implemented in the CRAC (Calculations of Reactor Accident Consequences) Code are described and critiqued. The major elements analyzed are those concerning dosimetry, early effects, and late effects. The published comments on the models are summarized, as are the important findings since the publication of the RSS.

  15. Evolution of International Space Station Program Safety Review Processes and Tools

    Science.gov (United States)

    Ratterman, Christian D.; Green, Collin; Guibert, Matt R.; McCracken, Kristle I.; Sang, Anthony C.; Sharpe, Matthew D.; Tollinger, Irene V.

    2013-01-01

    The International Space Station Program at NASA is constantly seeking to improve the processes and systems that support safe space operations. To that end, the ISS Program decided to upgrade their Safety and Hazard data systems with 3 goals: make safety and hazard data more accessible; better support the interconnection of different types of safety data; and increase the efficiency (and compliance) of safety-related processes. These goals are accomplished by moving data into a web-based structured data system that includes strong process support and supports integration with other information systems. Along with the data systems, ISS is evolving its submission requirements and safety process requirements to support the improved model. In contrast to existing operations (where paper processes and electronic file repositories are used for safety data management) the web-based solution provides the program with dramatically faster access to records, the ability to search for and reference specific data within records, reduced workload for hazard updates and approval, and process support including digital signatures and controlled record workflow. In addition, integration with other key data systems provides assistance with assessments of flight readiness, more efficient review and approval of operational controls and better tracking of international safety certifications. This approach will also provide new opportunities to streamline the sharing of data with ISS international partners while maintaining compliance with applicable laws and respecting restrictions on proprietary data. One goal of this paper is to outline the approach taken by the ISS Progrm to determine requirements for the new system and to devise a practical and efficient implementation strategy. From conception through implementation, ISS and NASA partners utilized a user-centered software development approach focused on user research and iterative design methods. The user-centered approach used on

  16. Safety and efficacy outcomes of infrapopliteal endovascular procedures performed in patients with critical limb ischemia according to the Society for Vascular Surgery objective performance goals.

    Science.gov (United States)

    Varela, Cesar; Acin, Francisco; Lopez de Maturana, Ignacio; de Haro, Joaquin; Bleda, Silvia; Paz, Belky; Esparza, Leticia

    2014-02-01

    Objective performance goals (OPGs) are a set of standardized end points generated from well documented historical controls against which new therapeutic procedures may be compared in single-arm studies. Recently, the Society for Vascular Surgery suggested a set of OPGs designed from vein bypass controls that could be used to evaluate the safety and efficacy of endovascular devices applied to critical limb ischemia through a noninferiority analysis. Our aim is to analyze the results of infrapopliteal endovascular procedures performed in patients with critical limb ischemia according to these OPG end points. This is a retrospective study of 121 infrapopliteal endovascular procedures. The tibial intervention was combined with a femoropopliteal angioplasty in 70 procedures. Major adverse cardiovascular events (MACEs), major adverse limb events (MALEs), and major amputations at 30 days were recorded as safety outcomes. Freedom from any MALE or perioperative death (Freedom from MALE + POD) and amputation-free survival were calculated as primary efficacy end points at both 12 months and at 8 years. The 95% confidence intervals (CIs) of all the end points were calculated to perform a noninferiority comparison using OPGs as the reference. The incidence of MACEs, MALEs, and amputation at 30 days were 5% (95% CI: 2-10% [OPG-MACE amputation 67%]) and an amputation-free survival of 78% (95% CI: 69-85% [OPG-amputation-free survival >68%]) at 12 months. Freedom from MALE + POD and amputation-free survival at 8 years decreased to 60% (95% CI: 49-69%) and to 26% (95% CI: 11-44%), respectively. Infrapopliteal endovascular procedures performed in everyday vascular surgery practice could meet the main OPG end points proposed for catheter-based treatment of critical limb ischemia. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. An 11-Year Review of the TARP Procedure in the Treatment of Atlantoaxial Dislocation.

    Science.gov (United States)

    Yin, Qing-Shui; Li, Xue-Shi; Bai, Zhao-Hui; Mai, Xiao-Hong; Xia, Hong; Wu, Zeng-Hui; Ma, Xiang-Yang; Ai, Fu-Zhi; Wang, Jian-Hua; Zhang, Kai

    2016-10-01

    Retrospective study. The aim of the study was to introduce the surgical techniques and evaluate the clinical outcomes of transoral atlantoaxial reduction plate (TARP) for the treatment of atlantoaxial dislocation. Researchers have reported on transoral plate internal fixation for the treatment of irreducible atlantoaxial dislocation (IAAD) without long-term follow-up and detailed clinical experience. The clinical records of 388 patients with atlantoaxial dislocation (IAAD, 340 cases; fixed atlantoaxial dislocation [FAAD], 48 cases) who received the TARP procedure from April 2003 to September 2014 were retrospectively reviewed. They were treated separately with TARP-I or TARP-II (82 cases), TARP-III (248 cases), or TARP-IV (58 cases). X-ray and magnetic resonance imaging were used to evaluate the efficacy of reduction and the degree of decompression, respectively. The long-term clinical outcome was evaluated by Japanese Orthopaedic Association scoring and the Symon and Lavender standard. Immediate reduction was achieved for all the patients with IAAD (340/340), whereas anatomical reduction was achieved for 98.2% of patients (334/340). Anatomical reduction was achieved in 87.5% of patients with FAAD (42/48). The average degree of spinal cord decompression ranged from 75% to 100% with an average of 88.4%. The clinical data of 106 patients were evaluated in the latest follow-up (12-108 mo, average 60.5 mo). The average spinal cord improvement rate by Japanese Orthopaedic Association scoring was 62.1%. According to the Symon and Lavender standard, there were 85 cases rated as markedly effective, 104 cases as effective, and 2 cases as noneffective. The overall markedly effective rate was 80% and the effective rate was 98%. The TARP procedure showed good anterior atlantoaxial release, reduction, decompression, and internal fixation for patients with IAAD and FAAD through a single anterior approach. It has the advantages of three-dimensional immediate atlantoaxial

  18. A proposal for a new arteriovenous malformation grading scale for neuroendovascular procedures and literature review.

    Science.gov (United States)

    Feliciano, Caleb E; de León-Berra, Ramón; Hernández-Gaitán, Manuel S; Rodríguez-Mercado, Rafael

    2010-06-01

    Traditionally, decisions regarding treatment and outcomes for patients with cerebral arteriovenous malformations (AVM) have made use of the Spetzler-Martin grading scale. The latter has withstood the test of time in clinical practice for AVM patients managed surgically and even when comparing studies involving other modalities of treatment. Recent awareness on the applicability of the grading system for risk assessment and outcome determination in cases of treatment by neuroendovascular means has emerged. We propose a preliminary grading system for neuroendovascular procedures based on a revision of the available literature. A literature search using the keywords 'arteriovenous malformation', 'embolization' and 'outcome' was done. Articles studying the factors involved in complications and outcome determination for endovascular cerebral AVM patients were reviewed. These were tabulated and those dealing with anatomical, radiological and hemodynamic descriptions that were noted as significant determinants of risk or clinical outcome were used for development of a preliminary grading system to be used in a follow-up validation study. A grading system similar to the Spetzler-Martin grading scale was developed using factors deemed in the literature as significant determinants of outcome. The classification includes the number of feeding vessels into the AVM, the eloquence of adjacent areas, and the presence of fistulous components. Follow-up study is underway at our institution to validate our proposal. Yet, significant evidence exists in the literature validating those factors as stand alone determinants of outcome and risk, suggesting that this grading scale may well be applicable to endovascular embolization procedures. A grading scale similar to the Spetzler-Martin grading system for use in risk assessment and outcome determination in brain AVM patients treated by endovascular techniques seems adequate and clinically feasible. Studies on applicability and validation

  19. Efficacy and safety of acupuncture in children: an overview of systematic reviews.

    Science.gov (United States)

    Yang, Chunsong; Hao, Zilong; Zhang, Ling-Li; Guo, Qin

    2015-08-01

    In recent years, acupuncture has increasingly being integrated into pediatric health care. It was used on ~150,000 children (0.2%). We aim to update the evidence for the efficacy and safety of acupuncture for children and evaluate the methodological qualities of these studies to improve future research in this area. We included 24 systematic reviews, comprising 142 randomized controlled trials (RCTs) with 12,787 participants. Only 25% (6/24) reviews were considered to be high quality (10.00 ± 0.63). High-quality systematic reviews and Cochrane systematic reviews tend to yield neutral or negative results (P = 0.052, 0.009 respectively). The efficacy of acupuncture for five diseases (Cerebral Palsy (CP), nocturnal enuresis, tic disorders, amblyopia, and pain reduction) is promising. It was unclear for hypoxic ischemic encephalopathy, attention deficit hyperactivity disorder, mumps, autism spectrum disorder (ASD), asthma, nausea/vomiting, and myopia. Acupuncture is not effective for epilepsy. Only six reviews reported adverse events (AEs) and no fatal side effects were reported. The efficacy of acupuncture for some diseases is promising and there have been no fatal side effects reported. Further high-quality studies are justified, with five diseases in particular as research priorities.

  20. Investigation of practices and procedures in the use of therapeutic diathermy: A study from the physiotherapists' health and safety perspective

    OpenAIRE

    Shah, SGS; FARROW, A.

    2007-01-01

    Background and Purpose. The safe use of therapeutic diathermy requires practices and procedures that ensure compliance to professional guidelines and clinical evidence. Inappropriate use may expose physiotherapists and other people in the vicinity of operating diathermy devices to stray radiofrequency electromagnetic fields, which can be a source of risk and may lead to adverse health effects. The aim of the present study was to investigate practices and procedures for therapeutic diathermy f...

  1. Is There a Role for Arnica and Bromelain in Prevention of Post-Procedure Ecchymosis or Edema? A Systematic Review of the Literature.

    Science.gov (United States)

    Ho, Derek; Jagdeo, Jared; Waldorf, Heidi A

    2016-04-01

    The management of postprocedure skin care is of significant interest to dermatologists and other physicians. Ecchymosis and edema are common temporary postprocedure unwanted effects. Two botanically-derived products, arnica and bromelain, are used internationally by physicians to limit ecchymosis and edema that occur secondary to cosmetic, laser, and surgical skin procedures. The authors review the published literature and provide evidence-based recommendations on arnica and bromelain for prevention and treatment of postprocedure ecchymosis and edema. A search of the computerized bibliographic databases Medline, EMBASE, Scopus, and CINAHL was performed on March 23, 2015. The key terms used were "arnica," and "bromelain." This review contains clinical trials that evaluated prevention and/or treatment of postprocedure ecchymosis or edema with oral arnica (11), topical arnica (2), and oral bromelain (7). No studies on topical bromelain were found. Clinical trials on arnica and bromelain have demonstrated mixed results. Some randomized controlled trials reported improvement postprocedure with arnica (4/13) and bromelain (5/7). Based upon published studies, there is insufficient data to support use of arnica and bromelain post procedure, and the authors recommend additional research to determine the efficacy and safety of arnica and bromelain to prevent and/or treat ecchymosis and edema in patients.

  2. Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity.

    Science.gov (United States)

    Huss, Michael; Duhan, Praveen; Gandhi, Preetam; Chen, Chien-Wei; Spannhuth, Carsten; Kumar, Vinod

    2017-01-01

    Attention-deficit/hyperactivity disorder (ADHD) is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH), a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear. Here we review the available literature on MPH dose optimization from clinical trials and real-world experience on ADHD management. In addition, we report safety and efficacy data from the largest MPH modified-release long-acting Phase III clinical trial conducted to examine benefits of dose optimization in adults with ADHD. Overall, MPH is an effective ADHD treatment with a good safety profile; data suggest that dose optimization may enhance the safety and efficacy of treatment. Further research is required to establish the extent to which short-term clinical benefits of MPH dose optimization translate into improved long-term outcomes for patients with ADHD.

  3. Immunogenicity, effectiveness and safety of combined hepatitis A and B vaccine: a systematic literature review.

    Science.gov (United States)

    Bakker, Marina; Bunge, Eveline M; Marano, Cinzia; de Ridder, Marc; De Moerlooze, Laurence

    2016-07-01

    Hepatitis A and B are two of the most common vaccine-preventable diseases and vaccination for Hepatitis A virus (HAV) and hepatitis B virus (HBV) is recommended for those at risk of contracting HAV and/or HBV through their occupation, travel or lifestyle. To describe the vaccine efficacy, immunogenicity, effectiveness and safety of the combined vaccine against hepatitis A and hepatitis B. A systematic review of the literature published between 1990 and 2015. Anti-HAV seropositivity rates ranged from 96.2% to 100% and anti-HBs seroprotection rates from 82% to 100%. Antibodies persisted up to 15 years and geometric mean concentration (GMC) remained above the seropositivity cut-off value for both. Anti-HAV and anti-HBs immune responses were lower in less immunocompetent individuals one month after completion of the immunization schedule. The safety profiles of Twinrix(TM) and monovalent hepatitis A and B vaccines were similar. The vaccine offers satisfactory long-term immunogenicity rates, expected duration of protection and safety profile similar to the monovalent hepatitis A or B vaccines.

  4. Learning from Aviation to Improve Safety in the Operating Room - a Systematic Literature Review

    Directory of Open Access Journals (Sweden)

    Linda S. G. L. Wauben

    2012-01-01

    Full Text Available Lessons learned from other high-risk industries could improve patient safety in the operating room (OR. This review describes similarities and differences between high-risk industries and describes current methods and solutions within a system approach to reduce errors in the OR. PubMed and Scopus databases were systematically searched for relevant articles written in the English language published between 2000 and 2011. In total, 25 articles were included, all within the medical domain focusing on the comparison between surgery and aviation. In order to improve safety in the OR, multiple interventions have to be implemented. Additionally, the healthcare organization has to become a ‘learning organization’ and the OR team has to become a team with shared responsibilities and flat hierarchies. Interpersonal and technical skills can be trained by means of simulation and can be supported by implementing team briefings, debriefings and cross-checks. However, further development and research is needed to prove if these solutions are useful, practical, and actually increase safety.

  5. QMRA and water safety management: review of application in drinking water systems.

    Science.gov (United States)

    Petterson, S R; Ashbolt, N J

    2016-08-01

    Quantitative microbial risk assessment (QMRA), the assessment of microbial risks when model inputs and estimated health impacts are explicitly quantified, is a valuable tool to support water safety plans (WSP). In this paper, research studies undertaken on the application of QMRA in drinking water systems were reviewed, highlighting their relevance for WSP. The important elements for practical implementation include: the data requirements to achieve sufficient certainty to support decision-making; level of expertise necessary to undertake the required analysis; and the accessibility of tools to support wider implementation, hence these aspects were the focus of the review. Recommendations to support the continued and growing application of QMRA to support risk management in the water sector are provided.

  6. Occupational safety and health management in the construction industry: a review.

    Science.gov (United States)

    Jaafar, Mohd Hafiidz; Arifin, Kadir; Aiyub, Kadaruddin; Razman, Muhammad Rizal; Ishak, Muhammad Izzuddin Syakir; Samsurijan, Mohamad Shaharudin

    2017-09-11

    The construction industry plays a significant role in contributing to the economy and development globally. During the process of construction, various hazards coupled with the unique nature of the industry contribute to high fatality rates. This review refers to previous published studies and related Malaysian legislation documents. Four main elements consisting of human, worksite, management and external elements which cause occupational accidents and illnesses were identified. External and management elements are the underlying causes contributing to occupational safety and health (OSH), while human and worksite elements are more apparent causes of occupational accidents and illnesses. An effective OSH management approach is required to contain all hazards at construction sites. An approach to OSH management constructed by elements of policy, process, personnel and incentive developed in previous work is explored. Changes to the sub-elements according to previous studies and the related Malaysian legislation are also covered in this review.

  7. Safety of Animal Fats for Biodiesel Production: A Critical Review of Literature

    Energy Technology Data Exchange (ETDEWEB)

    Greene, A.; Dawson, P.; Nixon, D.; Atkins, J.; Pearl, G. [Clemson University, SC (United States)

    2007-05-15

    An in-depth review of available literature was conducted on the safety of using animal fats for biodiesel. The review indicated little or no known risk to human and animal health and to the environment relative to inherent microbial, organic or inorganic agents in animal fats destined for biodiesel production. Animal by-products are generated from the inedible tissues derived from meat, poultry and fish production. This material is thermally processed by the rendering industry to generate a number of industrial materials including use of the fat portion to produce biodiesel. As the biodiesel industry continues to develop, questions have emerged about the safety of animal versus vegetable fats for biodiesel production and utilization. The following report is the result of a detailed literature search into the potential microbial, organic, and inorganic contaminants that may be present in animal fats and the potential for human or environmental safety issues associated with each. The potential safety risks associated with prions are discussed in a separate report, 'Biodiesel from Specified Risk Material Tallow: An Appraisal of TSE Risks and their Reduction'. In certain instances, very little was reported about the potential contaminating moiety and its fate in biodiesel production and usage. Establishing an absolute zero risk assessment is impossible on any fat utilized for biodiesel production. Among the potential microbial contaminants, bacteria, viruses, fungi, yeast, parasites, and microbial toxins were considered. In each instance, the nature of the production process and usage of biodiesel via combustion reduce the possibility that microbial contaminants would be a cause for concern to humans, animals, or the environment. Potential organic moieties contaminating the fat should meet a similar fate. Current evidence suggests that metals and metalloids within animal fats will not cause significant safety issues in the production and use of rendered fat

  8. Review of Occupational Health and Safety Organization in Expanding Economies: The Case of Southern Africa.

    Science.gov (United States)

    Moyo, Dingani; Zungu, Muzimkhulu; Kgalamono, Spoponki; Mwila, Chimba D

    2015-01-01

    Globally, access to occupational health and safety (OHS) by workers has remained at very low levels. The organization and implementation of OHS in South Africa, Zimbabwe, Zambia, and Botswana has remained at suboptimal levels. Inadequacy of human resource capital, training, and education in the field of OHS has had a major negative impact on the improvement of worker access to such services in expanding economies. South Africa, Zimbabwe, Zambia, and Botswana have expanding economies with active mining and agricultural activities that pose health and safety risks to the working population. A literature review and country systems inquiry on the organization of OHS services in the 4 countries was carried out. Because of the infancy and underdevelopment of OHS in southern Africa, literature on the status of this topic is limited. In the 4 countries under review, OHS services are a function shared either wholly or partially by 3 ministries, namely Health, Labor, and Mining. Other ministries, such as Environment and Agriculture, carry small fragments of OHS function. The 4 countries are at different stages of OHS legislative frameworks that guide the practice of health and safety in the workplace. Inadequacies in human resource capital and expertise in occupational health and safety are noted major constraints in the implementation and compliance to health and safety initiatives in the work place. South Africa has a more mature system than Zimbabwe, Zambia, and Botswana. Lack of specialized training in occupational health services, such as occupational medicine specialization for physicians, has been a major drawback in Zimbabwe, Zambia, and Botswana. The full adoption and success of OHS systems in Southern Africa remains constrained. Training and education in OHS, especially in occupational medicine, will enhance the development and maturation of occupational health in southern Africa. Capacitating primary health services with basic occupational health knowledge would

  9. A procedure for the safety evaluation of natural flavor complexes used as ingredients in food: Essential oils

    NARCIS (Netherlands)

    Smith, R.L.; Cohen, S.M.; Doull, J.; Feron, V.J.; Goodman, J.I.; Marnett, L.J.; Portoghese, P.S.; Waddell, W.J.; Wagner, B.M.; Hall, R.L.; Higley, N.A.; Lucas-Gavin, C.; Adams, T.B.

    2005-01-01

    A scientifically based guide has been developed to evaluate the safety of naturally occurring mixtures, particularly essential oils, for their intended use as flavor ingredients. The approach relies on the complete chemical characterization of the essential oil and the variability of the composition

  10. Shift and night work and long working hours--a systematic review of safety implications.

    Science.gov (United States)

    Wagstaff, Anthony Sverre; Sigstad Lie, Jenny-Anne

    2011-05-01

    In order to devise effective preventive strategies, it is important to study workplace stressors that might increase the risk of workplace accidents - both affecting workers themselves as well as causing harm to third-parties. The aim of this report is to provide a systematic, updated overview and scientific review of empirical research regarding accidents in relation to long work hours and shift work, primarily based on epidemiological studies. The search for articles was part of a large review study on the effects of work hours on various health outcomes, safety, and performance. The search strategy included 5 international scientific databases, and nearly 7000 articles were initially identified using our search string. Following the application of inclusion and exclusion criteria, 443 publications were found and evaluated using a pre-defined scoring system. Of these, 43 concerned safety and accidents but only 14 were considered to be of high quality (total score 2 or 3 on a scale from 0-3) and therefore used for this study. Both shift work and long working hours present a substantial and well-documented detrimental effect on safety - all the studies that are included in this review have one or more significant findings in this respect. The trends are quite coherent although the increases in accident rates are mostly from 50% to 100%. In epidemiological terms, this may be seen as rather small differences. The use of such data is therefore only of importance if the accident incidence is high or if accidents may have large effects. The findings are most relevant to safety-critical activities such as the transport and health sectors. Work periods >8 hours carry an increased risk of accidents that cumulates, so that the increased risk of accidents at around 12 hours is twice the risk at 8 hours. Shift work including nights carries a substantial increased risk of accidents, whereas "pure" night work may bring some protection against this effect due to

  11. Trauma case review: A quality and safety feature of the Victorian State Trauma System.

    Science.gov (United States)

    Pinto, Carolyn; Cameron, Peter A; Gabbe, Belinda; McLellan, Susan; Walker, Tony

    2017-11-07

    The aim of the present study was to describe the trauma case review process and its role in a regionalised trauma system. Victoria has a population of 5.9 million people, accounting for 26% of Australia's population. Victoria has been serviced by an inclusive, organised trauma system since 2000 comprising 138 health services with trauma designations and three major trauma services. Pre- and interhospital guidelines prescribe the timely transport of patients to the appropriate level of trauma service. A review of the role and contribution of 10 years of operation of the trauma case review group (CRG) was undertaken to describe the aims, processes and governance surrounding the implementation of an individual case review for specified major trauma patients. Specified patients were those identified by the Victorian State Trauma Registry as being managed outside of established Victorian State Trauma System prehospital and interhospital guidelines. A state-wide trauma case review process was implemented across the trauma system using data-informed detection flags and screening criteria. Using data from the Victorian State Trauma Registry, detection flags were correlated with patients at risk of a poorer outcome, thereby ensuring that all patients managed outside of the requirements of established trauma triage and transfer guidelines were subject to review. The CRG provides an individual review process as a technique for assessing and monitoring major trauma patient care and compliance with trauma system triage and transfer guidelines. The process has been effective as a quality and safety strategy by improving clinician knowledge of major trauma triage and transfer guidelines and facilitating improved compliance, particularly with interhospital transfers. Strong compliance has been achieved from health services with the requirement to internally review and respond to CRG concerns regarding 'high-risk' trauma cases. Anecdotal feedback from health services regarding

  12. Qualitative Risk Assessment for an LNG Refueling Station and Review of Relevant Safety Issues

    Energy Technology Data Exchange (ETDEWEB)

    Siu, N.; Herring, J.S.; Cadwallader, L.; Reece, W.; Byers, J.

    1998-02-01

    This report is a qualitative assessment of the public and worker risk involved with the operation of a liquefied natural gas (LNG) vehicle refueling facility. This study includes facility maintenance and operations, tank truck deliveries, and end-use vehicle fueling; it does not treat the risks of LNG vehicles on roadways. Accident initiating events are identified by using a Master Logic Diagram, a Failure Modes and Effects Analysis, and historical operating experiences. The event trees were drawn to depict possible sequences of mitigating events following the initiating events. The phenomenology of LNG and other vehicle fuels is discussed to characterize the hazard posed by LNG usage. Based on the risk modeling and analysis, recommendations are given to improve the safety of LNG refueling stations in the areas of procedures and training, station design, and the dissemination of ``best practice`` information throughout the LNG community.

  13. Interim qualitative risk assessment for an LNG refueling station and review of relevant safety issues

    Energy Technology Data Exchange (ETDEWEB)

    Siu, N.; Herring, S.; Cadwallader, L.; Reece, W.; Byers, J.

    1997-07-01

    This report is a qualitative assessment of the public and worker risk involved with the operation of a liquefied natural (LNG) vehicle refueling facility. This study includes facility maintenance and operations, tanker truck delivers and end-use vehicle fueling; it does not treat the risks of LNG vehicles on roadways. Accident initiating events are identified by using a Master Logic Diagram, a Failure Modes and Effects analysis and historical operating experiences. The event trees were drawn to depict possible sequences of mitigating events following the initiating events. The phenomenology of LNG and other vehicle fuels is discussed to characterize the hazard posed by LNG usage. Based on the risk modeling and analysis, recommendations are given to improve the safety of LNG refueling stations in the areas of procedures and training, station design, and the dissemination of best practice information throughout the LNG community.

  14. A review on leadership of head nurses and patient safety and quality of care.

    Science.gov (United States)

    Verschueren, Marc; Kips, Johan; Euwema, Martin

    2013-01-01

    The purpose of the study was to explore in literature what different leadership styles and behaviors of head nurses have a positive influence on the outcomes of patient safety or quality of care. We reviewed the literature from January 2000 until September 2011. We searched Pubmed, Embase, Cinahl, Psychlit, and Econlit. We found 10 studies addressing the relationship between head nurse leadership and safety and quality. A wide array of styles and practices were associated with different patient outcomes. Transformational leadership was the most used concept in the studies. A trend can be observed over these studies suggesting that a trustful relationship between the head nurse and subordinates is an important driving force for the achievement of positive patient outcomes. Furthermore, the effects of these trustful relationships seem to be amplified by supporting mechanisms, often objective conditions like clinical pathways and, especially, staffing level. This study offers an up-to-date review of the limited number of studies on the relationship between nurse leadership and patient outcomes. Although mostly transformational leadership was found to be responsible for positive associations with outcomes, also contingent reward had positive influence on outcomes. We formulated some comments on the predominance of the transformational leadership concept and suggested the application of complexity theory and political leadership for the current context of care. We formulated some implications for practice and further research, mainly the need for more systematic empirical and cross cultural studies and the urgent need for the development of a validated set of nurse-sensitive patient outcome indicators.

  15. Efficacy and safety of pregabalin in generalised anxiety disorder: A critical review of the literature.

    Science.gov (United States)

    Baldwin, David S; den Boer, Johan A; Lyndon, Gavin; Emir, Birol; Schweizer, Edward; Haswell, Hannah

    2015-10-01

    The aim of this review is to summarise the literature on the efficacy and safety of pregabalin for the treatment of generalised anxiety disorder (GAD). Of 241 literature citations, 13 clinical trials were identified that were specifically designed to evaluate the efficacy and safety of pregabalin in GAD, including 11 randomised double-blind trials and two open-label studies. Pregabalin efficacy has been consistently demonstrated across the licensed dose range of 150-600 mg/day. Efficacy has been reported for pregabalin monotherapy in elderly patients with GAD, patients with severe anxiety, and for adjunctive therapy when added to a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor in patients who have failed to respond to an initial course of antidepressant therapy. The two most common adverse events with pregabalin are somnolence and dizziness, both of which appear to be dose-related. Pregabalin appears to have a low potential for causing withdrawal symptoms when long-term therapy is discontinued; however, tapering over the course of at least one week is recommended. A review of available evidence indicates that pregabalin is a well-tolerated and consistently effective treatment for GAD, with a unique mechanism of action that makes it a useful addition to the therapeutic armamentarium. © The Author(s) 2015.

  16. On-board safety monitoring systems for driving: review, knowledge gaps, and framework.

    Science.gov (United States)

    Horrey, William J; Lesch, Mary F; Dainoff, Marvin J; Robertson, Michelle M; Noy, Y Ian

    2012-02-01

    Fatal highway incidents remain the leading type of fatal work-related event, carrying tremendous personal, social, and economic costs. While employers with a fixed worksite can observe and interact directly with workers in an effort to promote safety and reduce risk, employers with workers who operate a motor vehicle as part of their job have fewer options. New technologies such as on-board safety monitoring systems offer the potential to further improve safety. These technologies allow vehicle owners to collect safety-specific information related to a driver's on-the-road behavior and performance. While many such devices are being developed and implemented in both commercial fleets and private vehicles, the scientific examination of these devices has lagged by comparison. In the current paper, we: (a) describe the general features and functionality of current generations of on-board monitoring devices and how they might impact various driver behaviors; (b) review the current state of scientific knowledge specific to on-board devices; (c) discuss knowledge gaps and potential areas for future research, borrowing from the related domain of computer-based electronic performance monitoring (EPM); and (d) propose a framework that can be used to explore some of the human-system interactions pertaining to monitoring systems. Motor vehicle crashes can carry tremendous costs for employers, in terms of injury, disability, and loss of potentially productive work years. New technologies can offer tremendous benefits in terms of promoting safer on-the-road behaviors. Copyright © 2012 Elsevier Ltd. All rights reserved.

  17. Fructus Ligustri Lucidi in Osteoporosis: A Review of its Pharmacology, Phytochemistry, Pharmacokinetics and Safety.

    Science.gov (United States)

    Chen, Beibei; Wang, Lili; Li, Lin; Zhu, Ruyuan; Liu, Haixia; Liu, Chenyue; Ma, Rufeng; Jia, Qiangqiang; Zhao, Dandan; Niu, Jianzhao; Fu, Min; Gao, Sihua; Zhang, Dongwei

    2017-09-05

    Background : Fructus Ligustri Lucidi (FLL) has now attracted increasing attention as an alternative medicine in the prevention and treatment of osteoporosis. This study aimed to provide a general review of traditional interpretation of the actions of FLL in osteoporosis, main phytochemical constituents, pharmacokinetics, pharmacology in bone improving effect, and safety. Materials and Methods : Several databases, including PubMed, China National Knowledge Infrastructure, National Science and Technology Library, China Science and Technology Journal Database, and Web of Science were consulted to locate publications pertaining to FLL. The initial inquiry was conducted for the presence of the following keywords combinations in the abstracts: Fructus Ligustri Lucidi , osteoporosis, phytochemistry, pharmacokinetics, pharmacology, osteoblasts, osteoclasts, salidroside. About 150 research papers and reviews were consulted. Results : FLL is assumed to exhibit anti-osteoporotic effects by improving liver and kidney deficiencies and reducing lower back soreness in Traditional Chinese Medicine (TCM). The data from animal and cell experiments demonstrate that FLL is able to improve bone metabolism and bone quality in ovariectomized, growing, aged and diabetic rats through the regulation of PTH/FGF-23/1,25-(OH)₂D₃/CaSR, Nox4/ROS/NF-κB, and OPG/RANKL/cathepsin K signaling pathways. More than 100 individual compounds have been isolated from this plant. Oleanolic acid, ursolic acid, salidroside, and nuzhenide have been reported to exhibit the anti-osteoporosis effect. The pharmacokinetics data reveals that salidroside is one of the active constituents, and that tyrosol is hard to detect under physiological conditions. Acute and subacute toxicity studies show that FLL is well tolerated and presents no safety concerns. Conclusions : FLL provides a new option for the prevention and treatment of osteoporosis, which attracts rising interests in identifying potential anti

  18. A systematic review on diagnostic procedures for specific language impairment: The sensitivity and specificity issues.

    Science.gov (United States)

    Shahmahmood, Toktam Maleki; Jalaie, Shohreh; Soleymani, Zahra; Haresabadi, Fatemeh; Nemati, Parvin

    2016-01-01

    Identification of children with specific language impairment (SLI) has been viewed as both necessity and challenge. Investigators and clinicians use different tests and measures for this purpose. Some of these tests/measures have good psychometric properties, but it is not sufficient for diagnostic purposes. A diagnostic procedure can be used for identification a specific population with confidence only when its sensitivity and specificity are acceptable. In this study, we searched for tests/measures with predefined sensitivity and specificity for identification of preschool children with SLI from their typically developing peers. A computerized search in bibliographic databases from 2000 to August 2015 was performed with the following keywords: "specific language impairment" or SLI" and "primary language impairment" or 'PLI' with at least one of the followings: "diagnosis," "identification," "accuracy," "sensitivity," and "specificity." In addition, the related citations and reference lists of the selected articles were considered. The results of reviewing 23 included studies show that the index measures used in studies vary in accuracy with the sensitivity ranging from 16% to 100% and the specificity ranging from 14% to 100%. These varieties in sensitivity and specificity of different tests/measures confirm the necessity of attention to the diagnostic power of tests/measures before their use as diagnostic tool. Further, the results indicate there are some promising tests/measures that the available evidence supports their performances in the diagnosis of SLI in preschool-aged children, yet the place of a reference standard for the diagnosis of SLI is vacant among investigations.

  19. Irreversible electroporation for unresectable hepatocellular carcinoma: initial experience and review of safety and outcomes.

    Science.gov (United States)

    Cheung, W; Kavnoudias, H; Roberts, S; Szkandera, B; Kemp, W; Thomson, K R

    2013-06-01

    The aims of this study were to evaluate the safety, feasibility and tumour response of _irreversible electroporation, a non-thermal ablation technique, for the treatment of unresectable hepatocellular carcinoma. The endpoints were safety and local treatment efficacy. Patients with unresectable tumours and tumours not amenable for radiofrequency _ablation because of their vicinity to organs vulnerable to thermal damage such as the bowel or because they were close to large blood vessels that would limit efficacy of ablation due to the heat sink effect were treated with irreversible electroporation using percutaneous _ultrasound and/or computed tomography guided electrode placement between November 2008 and _December 2009. Early, late, minor and major complications were recorded. Tumour response was determined on triphasic helical computed tomography follow-up at one month, then every three months post-procedure. Eleven patients received IRE therapy to 18 HCC lesions (Mean diameter 2.44 ± 0.99 cm; range 1.0-6.1 cm) with five patients having more than one treated HCC. Mean follow-up was 18 months (range 14-24 months). Six patients required repeat treatments for local residual or recurrent disease; two of these also had IRE for distant intrahepatic recurrence. No serious complications were observed despite seven lesions lying adjacent to important structures or organs. Four patients developed transient urinary retention and seven developed transient local post-procedure pain. After IRE therapy, 13 (72%) lesions were completely ablated with 93% success for lesions ≤ 3 cm (13/14). The local recurrence-free period was 18 ± 4 months and the distance recurrence free period was 14 ± 6 months. These preliminary results suggest that IRE is a safe and feasible technique for local ablation of HCC, particularly for lesions less than 3 cm. No major complications were encountered during this study even for tumours close to essential structures or organs.

  20. Microvascular decompression for hemifacial spasm: A systematic review of vascular pathology, long term treatment efficacy and safety.

    Science.gov (United States)

    Sharma, Ravi; Garg, Kanwaljeet; Agarwal, Samagra; Agarwal, Deepak; Chandra, P Sarat; Kale, Shashank S; Sharma, Bhawani S; Mahapatra, Ashok K

    2017-01-01

    Hemifacial spasm (HS) is a rare disorder caused by the compression of facial nerve root exit zone (REZ) at the brainstem by a vascular loop. Microvascular decompression (MVD) is a popular treatment modality for HS. The purpose of this study was to determine the long-term efficacy and safety of MVD for HS by assessing the effect of the procedure from the literature published over the last 25 years. A systematic data review from 1992 to 2015 using specific eligibility criteria yielded 27 studies on MVD for HS, the data of which were pooled and subjected to a meta-analysis. The pooled odds ratio (OR) revealed by the meta-analysis showed that anterior inferior cerebellar artery was the most common offending vessel in 37.8% (95% confidence interval [CI]: 27.8-47.7%) of the patients. Complete resolution of HS was seen in 88.5% (95% CI: 86.7-90.4%) of the patients after a long-term follow up. The complication rate was low following MVD, the most common being temporary facial paresis in 5.9% (95% CI: 4.3-7.5%) of patients. MVD is a safe and effective treatment for HS with long-term benefits and a low complication rate.

  1. Safety system status monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Lewis, J.R.; Morgenstern, M.H.; Rideout, T.H.; Cowley, P.J.

    1984-03-01

    The Pacific Northwest Laboratory has studied the safety aspects of monitoring the preoperational status of safety systems in nuclear power plants. The goals of the study were to assess for the NRC the effectiveness of current monitoring systems and procedures, to develop near-term guidelines for reducing human errors associated with monitoring safety system status, and to recommend a regulatory position on this issue. A review of safety system status monitoring practices indicated that current systems and procedures do not adequately aid control room operators in monitoring safety system status. This is true even of some systems and procedures installed to meet existing regulatory guidelines (Regulatory Guide 1.47). In consequence, this report suggests acceptance criteria for meeting the functional requirements of an adequate system for monitoring safety system status. Also suggested are near-term guidelines that could reduce the likelihood of human errors in specific, high-priority status monitoring tasks. It is recommended that (1) Regulatory Guide 1.47 be revised to address these acceptance criteria, and (2) the revised Regulatory Guide 1.47 be applied to all plants, including those built since the issuance of the original Regulatory Guide.

  2. A systematic review on the safety of Prostar XL versus ProGlide after TAVR and EVAR

    Energy Technology Data Exchange (ETDEWEB)

    Maniotis, Christos [2nd Cardiology Department, Hellenic Red Cross Hospital of Athens, Athens (Greece); Andreou, Constantinos; Karalis, Ioannis [Interventional Cardiology Department, University Hospital of Leiden, Leiden (Netherlands); Koutouzi, Giasemi [Interventional Radiology Department, Sahlgrenska University Hospital, Gothenburg (Sweden); Agelaki, Maria [2nd Cardiology Department, Hellenic Red Cross Hospital of Athens, Athens (Greece); Koutouzis, Michael, E-mail: koutouzismike@yahoo.gr [2nd Cardiology Department, Hellenic Red Cross Hospital of Athens, Athens (Greece)

    2017-03-15

    Background: Endovascular aortic aneurysm repair (EVAR) and transfemoral transcatheter aortic valve replacement (TAVR) are widely spreading minimally invasive procedures performed mainly through the femoral artery. Prostar XL and ProGlide vascular closure devices are used in clinical practice for the hemostasis in these procedures and they have been shown to be safe and effective. Purpose: The aim of our systematic review is to compare the safety of these two devices for percutaneous closure of large arteriotomies in patients undergoing TAVR and EVAR. Methods: We searched PubMed, EMBASE, Google Scholar and the Cochrane Central Register of Controlled Trials for all randomized and observational published studies that compared Prostar XL vs. ProGlide. Relative risk was calculated by random-effects model. Review Manager 5.1 was used for statistical analysis. Results: A total number of 2909 patients were included in our analysis. The rate of overall vascular complications did not differ between Prostar XL and ProGlide {RR 1.35 (0.80–2.29), p = 0.27}. In contrary, the risk ratio of all bleeding complications with Prostar XL compared to ProGlide was 1.82 (1.47–2.24, p < 0.001) and for major and life-threatening bleeding complications was 2.48 (1.65–3.73, p < 0001, suggesting a lower bleeding risk with ProGlide). No statistical difference was found between groups for end-stage acute kidney injury (AKI), with a risk ratio of 2.14 (0.81–5.66), p = 0.05. Finally, there were no differences in in-hospital and 30-days mortality rate between the two groups (1.41, 0.56–3.54, p = 0.46 and 1.43, 0.55–3.73, p = 0.47, respectively). Conclusions: Prostar XL is associated with greater risk of any bleeding as well as life threatening bleeding compared to the ProGlide device. However, no significant differences were observed in the rate of overall vascular complications, end stage AKI and in-hospital and 30-days mortality. - Highlights: • We present a systematic review

  3. Meta-analysis and review: effectiveness, safety, and central port design of the intraocular collamer lens

    Directory of Open Access Journals (Sweden)

    Packer M

    2016-06-01

    Full Text Available Mark Packer Mark Packer MD Consulting, Inc., Boulder, CO, USA Abstract: The purpose of this review is to summarize relevant data from publications appearing in the peer-reviewed scientific literature over the past decade since US Food and Drug Administration approval of the implantable collamer lens (ICL, and, in particular, to review studies relating to sizing methodology, safety, and effectiveness, as well as more recent studies reporting clinical outcomes of the V4c Visian ICL with KS Aquaport, VICMO. A literature search was conducted using two databases, PubMed.gov and Science.gov, to identify all articles published after 2005 related to the Visian ICL (STAAR Surgical, Inc.. Articles were examined for their relevance to sizing methodology, clinical safety, and effectiveness, and the references cited in each article were also searched for additional relevant publications. The literature review revealed that all currently reported methods of determining the best-fit size of the ICL achieve similarly satisfactory results in terms of vault, the safe distance between the crystalline lens and the ICL. Specifically, meta-analysis demonstrated that sulcus-to-sulcus and white-to-white measurement-based sizing methods do not result in clinically meaningful nor statistically significant differences in vault (two-sample two-sided t-test using pooled mean and standard deviations; t (2,594=1.33; P=0.18. The reported rates of complications related to vault are very low, except in two case series where additional risk factors such as higher levels of myopia and older age impacted the incidence of cataract. On the basis of preclinical studies and initial clinical reports, with up to 5 years of follow-up, the new VICMO central port design holds promise for further reduction of complications. Given its safety record and the significant improvement in vision and quality of life that the ICL makes possible, the benefits of ICL implantation outweigh the risks

  4. A Review of Sea State Estimation Procedures Based on Measured Vessel Responses

    DEFF Research Database (Denmark)

    Nielsen, Ulrik Dam

    2016-01-01

    The operation of ships requires careful monitoring of therelated costs while, at the same time, ensuring a high level of safety. A ship’s performance with respect to safety and fuel efficiency may be compromised by the encountered waves. Consequently, it is important to estimate the surrounding...

  5. Safety and clinical performance of kyphoplasty and SpineJack(®) procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.

    Science.gov (United States)

    Noriega, D C; Ramajo, R H; Lite, I S; Toribio, B; Corredera, R; Ardura, F; Krüger, A

    2016-06-01

    Clinical performance and safety of two percutaneous vertebral cement augmentation (VA) procedures (SpineJack® and Kyphx Xpander® balloon) were compared in patients with osteoporotic compression fractures. Both techniques were safe, efficient, and led to a rapid and marked improvement in clinical signs; nevertheless, SpineJack showed better restoration of vertebral heights and angles, maintained over time. In patients with osteoporotic vertebral compression fractures (VCFs), both SpineJack® (SJ) and balloon kyphoplasty (BKP) led to a rapid and marked improvement in clinical signs. This pilot, monocentric, investigator-initiated, prospective study aimed to compare two percutaneous vertebral augmentation procedures in the painful osteoporotic VCF treatment. Thirty patients were randomized to receive SJ (n = 15) or BKP (n = 15). Analgesic consumption, back pain intensity (visual analog scale (VAS)), and Oswestry Disability Index (ODI) scores were recorded preoperatively, at 5 days and 1, 3, 6, and 12 months post-surgery. Quality of life (EQ-VAS score) was evaluated at 1, 3, 6, and 12 months. Spine X-rays were taken 48 h prior to procedure and 5 days and 6 and 12 months after. SpineJack® led to a significantly shorter intervention period (23 vs 32 min; p SpineJack® procedure has a higher potential for vertebral body height restoration and maintenance over time.

  6. Review article: Efficacy and safety of methoxyflurane analgesia in the emergency department and prehospital setting.

    Science.gov (United States)

    Grindlay, Joanne; Babl, Franz E

    2009-02-01

    This article reviews the evidence for the analgesic efficacy of methoxyflurane in both prehospital and ED settings, as well as the adverse event profile associated with methoxyflurane use. Although there are no published controlled trials of methoxyflurane in sub-anaesthetic doses, available data indicate that it is an efficacious analgesic. There is inadequate evidence regarding its use as an agent for procedural pain. Despite the potential for renal impairment evident when it was used in anaesthetic doses, no significant adverse effects have been reported in the literature, neither in patients nor occupationally, when the dose used is limited to that currently recommended.

  7. Patient Safety and Quality Improvement in Otolaryngology Education: A Systematic Review.

    Science.gov (United States)

    Gettelfinger, John D; Paulk, P Barrett; Schmalbach, Cecelia E

    2017-06-01

    Objective The breadth and depth of patient safety/quality improvement (PS/QI) research dedicated to otolaryngology-head and neck surgery (OHNS) education remains unknown. This systematic review aims to define this scope and to identify knowledge gaps as well as potential areas of future study to improved PS/QI education and training in OHNS. Data Sources A computerized Ovid/Medline database search was conducted (January 1, 1965, to May 15, 2015). Similar computerized searches were conducted using Cochrane Database, PubMed, and Google Scholar. Review Methods The study protocol was developed a priori using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Articles were classified by year, subspecialty, Institute of Medicine (IOM) Crossing the Chasm categories, and World Health Organization (WHO) subclass. Results Computerized searches yielded 8743 eligible articles, 267 (3.4%) of which met otolaryngology PS/QI inclusion criteria; 51 (19%) were dedicated to resident/fellow education and training. Simulation studies (39%) and performance/competency evaluation (23.5%) were the most common focus. Most projects involved general otolaryngology (47%), rhinology (18%), and otology (16%). Classification by the IOM included effective care (45%), safety/effective care (41%), and effective and efficient care (7.8%). Most research fell into the WHO category of "identifying solutions" (61%). Conclusion Nineteen percent of OHNS PS/QI articles are dedicated to education, the majority of which are simulation and focus on effective care. Knowledges gaps for future research include facial plastics PS/QI and the WHO category of "studies translating evidence into safer care."

  8. A review of case studies evaluating economic incentives to promote occupational safety and health.

    Science.gov (United States)

    Elsler, Dietmar; Treutlein, Daniela; Rydlewska, Iza; Frusteri, Liliana; Krüger, Henning; Veerman, Theo; Eeckelaert, Lieven; Roskams, Nele; Van Den Broek, Karla; Taylor, Terry N

    2010-06-01

    In many European countries, external economic incentives are discussed as a policy instrument to promote occupational safety and health (OSH) in enterprises. This narrative case study review aims to support policy-makers in organizations providing such incentives by supplying information about different incentive schemes and their main characteristics such as effectiveness, efficiency, and feasibility. The focal point and topic centre network of the European Agency for Safety and Health at Work were used to collect case studies about incentive schemes aimed at supporting the prevention of occupational accidents and diseases in enterprises. Such incentives are rarely described in the scientific literature. To be considered for this review, studies had to focus on external financial benefits that could be provided as part of an insurance-related incentive or a governmental subsidy scheme. In total, 14 cases were included in the review: 6 insurance premium- and 8 subsidy-based schemes. Of these, 13 contained an evaluation of the incentive scheme, of which 7 use quantitative criteria. Three cases provided sufficient data to conduct a cost-benefit analysis. Most qualitative evaluations related to the successful management of the program and the effectiveness of the promoted measures in the workplace. Regarding the latter, quantitative criteria covered accident rates, sick leave, and general improvement in working conditions. The cost-benefit analyses all resulted in a positive payout ratio, ranging from 1.01-4.81 euros return for every 1 euro invested. Generally, we found economic incentive schemes to be feasible and reasonably effective. However, analysis regarding the efficiency of such schemes is scarce and our evaluation of the cost-benefit analysis had to rely on few cases that, nevertheless, delivered positive results for large samples. Besides this finding, our study also revealed deficits in the quality of evaluations. In order to enable policy-makers to make

  9. Common handling procedures conducted in preclinical safety studies result in minimal hepatic gene expression changes in Sprague-Dawley rats.

    Directory of Open Access Journals (Sweden)

    Yudong D He

    Full Text Available Gene expression profiling is a tool to gain mechanistic understanding of adverse effects in response to compound exposure. However, little is known about how the common handling procedures of experimental animals during a preclinical study alter baseline gene expression. We report gene expression changes in the livers of female Sprague-Dawley rats following common handling procedures. Baseline gene expression changes identified in this study provide insight on how these changes may affect interpretation of gene expression profiles following compound exposure. Rats were divided into three groups. One group was not subjected to handling procedures and served as controls for both handled groups. Animals in the other two groups were weighed, subjected to restraint in Broome restrainers, and administered water via oral gavage daily for 1 or 4 days with tail vein blood collections at 1, 2, 4, and 8 hours postdose on days 1 and 4. Significantly altered genes were identified in livers of animals following 1 or 4 days of handling when compared to the unhandled animals. Gene changes in animals handled for 4 days were similar to those handled for 1 day, suggesting a lack of habituation. The altered genes were primarily immune function related genes. These findings, along with a correlating increase in corticosterone levels suggest that common handling procedures may cause a minor immune system perturbance.

  10. Report on inspection of concerns regarding the Martin Marietta Corporate Review of health and safety at Martin Marietta Energy Systems

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-01-18

    An Office of Inspector General Hotline allegation was received from an anonymous complainant regarding a July 1994 Martin Marietta Corporation Team`s health and safety review at three Department of Energy sites managed and operated by the then Martin Marietta Energy Systems. Inc. (Energy Systems), at Oak Ridge, Tennessee. We determined that the President of Energy Systems had requested a Corporate review at the three sites because of his concerns about safety incidents and accidents during the late Spring and early Summer of 1994. The Corporate Team`s charter was to determine if root causes existed for these safety incidents and accidents and to produce recommendations for the reduction or prevention of future safety incidents or accidents.

  11. Research on the maximum utilization of PSR (Periodic Safety Review) results

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Tae Myung; Lee, Jae Kyung; Ahn, Jin Chul; Kim, G. U.; Ryu, Y. S.; Lee, G. B.; Park, D. H. [Chungju Univ., Cheongju (Korea, Republic of)

    2002-03-15

    This is the final report of 'research on the maximum utilization of PSR results' focused on linkage strategy of PSR with continued operation over design life of operating NPP. Study was mace mainly on the analysis of current status of continued operation over plant design life in foreign countries, analysis of domestic PSR implementation status and establishment of basic strategy for linking PSR with continued operation. The results of the study performed so far can be summarized as below, the recent worldwide trend of promoting efficiency of NPP operation is focused on life extension of the plants rather than building of new. Considering the fact that some developed countries have already implemented the plant life extension and not a few countries at least have invested a good amount of fund for R and D of plant life management, we can not disregard the owner's request for review of life extension application without any reasonable description. As a result of investigation and analysis for the current status of continued operation over plant design life in foreign countries, it is concluded that most countries tend to link PSR with continued operation over plant design life and the extended operation has already been implemented in some developed countries. From the point, it turned out to be more desirable to couple those two systems for continued operation over plant design life of Korean NPP. A less than 7 years left until the end of design life for the oldest NPP Kori unit 1, it is strongly recommended to establish institutional frame including a legal basis and regulatory guidelines for continued operation over plant design life before long. For the prioritization methods of corrective actions in consideration of safety significance of shortcomings picked up from PSR, some related systems are reviewed including IAEA guidelines, PSR implementation experience of UK and US prioritization system for GSI (Generic Safety Issue). Basic principles are

  12. The effectiveness and s